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Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

Primary Purpose

Cataract, Lens Opacities

Status
Recruiting
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Implantation of trifocal IOL, Isatis TF (device under investigation)
Implantation of monofocal IOL, Isatis (control device)
Sponsored by
Cutting Edge SAS
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, IOL, hydrophobic, trifocal

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinically documented age-related cataract in both eyes with no comorbidity;
  • Calculated IOL power is within the range of the investigational IOLs;
  • Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes;
  • Regular corneal astigmatism (measured by topographer)
  • Astigmatism ≤1.0 D (measured by an automatic keratometer)
  • Clear intraocular media other than cataract;
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
  • Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion criteria applies only to the study group, not the control group);
  • Signed informed consent.

Exclusion Criteria:

  • Age of patient < 50 years;
  • Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer)
  • Irregular astigmatism (measured by topographer);
  • Difficulty for cooperation (distance from their home, general health conditions);
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders);
  • Subjects with AMD suspicious eyes as determined by OCT examination;
  • Previous intraocular or corneal surgery;
  • Traumatic cataract;
  • Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D;
  • Ocular hypertension, suspicious glaucoma or glaucoma;
  • Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
  • Expected complicated surgery;
  • Ocular surface disease (clinical symptoms or keratitis);
  • Pregnancy or lactation;
  • Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal);
  • Concurrent participation in another drug or device investigation.

In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including:

  • zonular instability;
  • need for iris manipulation;
  • capsular fibrosis or other opacity; and
  • inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.

Sites / Locations

  • Gemini Eye Clinic OstravaRecruiting
  • Gemini Eye Clinic Praha-KrcRecruiting
  • Gemini Eye Clinic ZlínRecruiting
  • Hospital DonostiaRecruiting
  • Oftalvist MadridRecruiting
  • Hospital Universitario Clínico San CarlosRecruiting
  • Hospital Miguel ServetRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IOL implantation experimental

IOL implantation active comparator

Arm Description

Experimental arm: Trifocal intraocular lens Isatis TF

Comparator arm: Monofocal intraocular lens Isatis

Outcomes

Primary Outcome Measures

Primary Safety Endpoint: Rates of Adverse Events
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Primary Performance Endpoint: Best Corrected Distance Visual Acuity
The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.

Secondary Outcome Measures

Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye.
Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye.

Full Information

First Posted
July 7, 2020
Last Updated
September 13, 2023
Sponsor
Cutting Edge SAS
Collaborators
targomedGmbH
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1. Study Identification

Unique Protocol Identification Number
NCT04465344
Brief Title
Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens
Official Title
Multicentric Clinical Study to Determine Safety and Efficacy of a Hydrophobic Acrylic Trifocal Intraocular Lens (IOL)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 31, 2021 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cutting Edge SAS
Collaborators
targomedGmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.
Detailed Description
This is a staged, multicentric, controlled, prospective, open-label clinical study whereby patients undergoing routine cataract surgery will have bilateral implantation of hydrophobic acrylic refractive trifocal intraocular lenses (Isatis TF) or the monofocal control device Isatis. The investigational device, Control lens and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient. The study will be carried out in up to five clinical centers in Spain. The device under investigation is a hydrophobic acrylic trifocal intraocular lens (IOL) manufactured by the sponsor of this study. The trifocality of this investigational device is based on a purely refractive principle with the goal to provide additional near and intermediate visual acuity with low photic side effects. The IOLs will be implanted in the course of routine cataract surgery and will benefit to patients suffering from cataract development. The control device (Isatis) is a hydrophobic acrylic monofocal intraocular lens to be implanted during cataract surgery. This control lens is CE approved and commercially available in Spain. Isatis monofocal lens is the parent lens of the device under investigation and both lenses share mechanical and material properties. In total 180 patients will be recruited for this clinical study and undergo bilateral implantation of the Isatis TF intraocular lens or Isatis lens in a 2:1 ratio. Subjects participating in the trial will attend a total of maximum 11 study visits over a period of 11-13 months. Subjects would have the option for unscheduled visits if required medically. Data analyses will be performed after the last patient finished the 120-180 days postoperative examination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Lens Opacities
Keywords
Intraocular Lens, IOL, hydrophobic, trifocal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IOL implantation experimental
Arm Type
Experimental
Arm Description
Experimental arm: Trifocal intraocular lens Isatis TF
Arm Title
IOL implantation active comparator
Arm Type
Active Comparator
Arm Description
Comparator arm: Monofocal intraocular lens Isatis
Intervention Type
Device
Intervention Name(s)
Implantation of trifocal IOL, Isatis TF (device under investigation)
Intervention Description
Patients will be implanted with study IOL in both eyes
Intervention Type
Device
Intervention Name(s)
Implantation of monofocal IOL, Isatis (control device)
Intervention Description
Patients will be implanted with Control IOL in both eyes
Primary Outcome Measure Information:
Title
Primary Safety Endpoint: Rates of Adverse Events
Description
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to reference data stated in the according ISO standard for posterior intraocular lenses (EN ISO 11979-7:2018) based on minimum 100 subjects.
Time Frame
120-180 days postoperative
Title
Primary Performance Endpoint: Best Corrected Distance Visual Acuity
Description
The primary performance endpoint is to show non inferiority of Isatis TF compared to the monofocal comparator in terms of best corrected distance visual acuity (CDVA) by means of statistical significance.
Time Frame
120-180 days postoperative
Secondary Outcome Measure Information:
Title
Secondary Safety Endpoint: Best Corrected Distance Visual Acuity compared to historical data
Description
The objective is to compare best corrected distance visual acuities (CDVA) above defined thresholds of the investigational product to the normative data stated in the according ISO norm (EN ISO 11979-7:2018) for posterior chamber intraocular lenses.
Time Frame
120-180 days postoperative
Title
Secondary Performance Endpoint: Distance Corrected Near Visual Acuity (DCNVA)
Description
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions on the first implanted eye.
Time Frame
120-180 days postoperative
Title
Secondary Performance Endpoint: Distance Corrected Intermediate Visual Acuity (DCIVA)
Description
Secondary performance endpoint is to show a statistically significant increase between pre-and postoperative findings on monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions on the first implanted eye.
Time Frame
120-180 days postoperative
Other Pre-specified Outcome Measures:
Title
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Description
Monocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
Preoperative, 1-2 days postoperative; 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Binocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Description
Binocular UDVA is measured with ETDRS charts placed in 4m distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
120-180 days postoperative, 330-420 days postoperative
Title
Monocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Description
Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Monocular Corrected Distance Visual Acuity (CDVA) under mesopic light conditions
Description
Monocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
Time Frame
120-180 days postoperative
Title
Binocular Corrected Distance Visual Acuity (CDVA) under photopic light conditions
Description
Binocular CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
120-180 days postoperative
Title
Monocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
Description
Monocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Binocular Uncorrected Intermediate Visual Acuity (UIVA) under photopic light conditions
Description
Binocular UIVA is measured with ETDRS charts placed in 66cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
120-180 days postoperative, 330-420 days postoperative
Title
Monocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
Description
Monocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Binocular Uncorrected Near Visual Acuity (UNVA) under photopic light conditions
Description
Binocular UNVA is measured with ETDRS charts placed in 40cm distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
120-180 days postoperative, 330-420 days postoperative
Title
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
Description
Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA) under mesopic light conditions
Description
Monocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
Time Frame
120-180 days postoperative
Title
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA) under photopic light conditions
Description
Binocular DCIVA is measured with ETDRS charts placed in 66cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
120-180 days postoperative
Title
Monocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
Description
Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done monocularly under photopic light conditions.
Time Frame
Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Monocular Distance Corrected Near Visual Acuity (DCNVA) under mesopic light conditions
Description
Monocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
Time Frame
120-180 days postoperative
Title
Binocular Distance Corrected Near Visual Acuity (DCNVA) under photopic light conditions
Description
Binocular DCNVA is measured with ETDRS charts placed in 40cm distance with corrective glasses for far distance according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
120-180 days postoperative
Title
Manifest refraction
Description
The manifest refraction is measured by means of a phoropter. The data contains values for sphere, cylinder and axis of cylinder according to ISO 11979-7:2018. This data will also be used to calculate the manifest refractive spherical equivalent (MRSE)
Time Frame
Preoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Adjusted Mean Refractive Spherical Equivalent (MRSE)
Description
The predictability of the postoperative manifest refraction will be evaluated using the absolute value of the adjusted MRSE calculated by the following formula: MRSEadjusted = MRSEpostop - MRSEtarget.
Time Frame
7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Binocular Defocus Curve
Description
To assess the visual acuity for different distances, defocus curves under photopic light conditions are measured. This test is performed with best distance corrected refraction and spherical additions ranging from -4.5 D to +2.0 D in 0.5 D steps. This examination is performed binocularly.
Time Frame
120-180 days postoperative
Title
Binocular Contrast Sensitivity under photopic light conditions
Description
Contrast Sensitivity under photopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
Time Frame
120-180 days postoperative
Title
Binocular Contrast Sensitivity under mesopic light conditions
Description
Contrast Sensitivity under mesopic light conditions using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
Time Frame
120-180 days postoperative
Title
Binocular Contrast Sensitivity under photopic light conditions and using a glare source
Description
Contrast Sensitivity under photopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
Time Frame
120-180 days postoperative
Title
Binocular Contrast Sensitivity under mesopic light conditions and using a glare source
Description
Contrast Sensitivity under mesopic light conditions with a glare source using the standardized contrast sensitivity device CSV-1000 (VectorVision). This examination is performed binocularly.
Time Frame
120-180 days postoperative
Title
Patient reported outcomes - Quality of Vision questionnaire [McAlinden et al, 2010]
Description
To assess the subjective perception of disturbances by photic phenomena, the validated and verified Quality of Vision (QoV) questionnaire will be used. This questionnaire is a linear-scaled 30-item instrument and is designed with 10 symptoms rated in each of three scales (frequency, severity, and bothersome). The QoV Questionnaire provides a QoV score in terms of symptom frequency, severity, and bothersome [McAlinden et al, 2010].
Time Frame
preoperative, 120-180 days postoperative
Title
Patient reported outcomes - Catquest-9SF 2011 questionnaire [Lundström et al, 2009]
Description
To assess if difficulties in daily life occur due to impaired sight. This questionnaire is a 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery [Lundström et al, 2009].
Time Frame
preoperative, 120-180 days postoperative
Title
Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
Description
The PRSIQ is a patient-reported measure assessing spectacle independence following cataract surgery. The analyses conducted provide evidence for the use of the PRSIQ total score as a measure of spectacle independence [Morlock et al, 2017].
Time Frame
preoperative, 120-180 days postoperative
Title
Pupil Size under photopic light conditions
Description
Photopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. In addition to the measurement with a ruler, pupil diameters under photopic light conditions will be recorded from the preoperative Pentacam measurement. For the photopic pupil diameters, eye illumination should be identical to that used for photopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
preoperative, 120-180 days postoperative
Title
Pupil Size under mesopic light conditions
Description
Mesopic pupil diameters are measured with a ruler allowing for a precision of at least +/-0.5 mm. For the mesopic pupil diameters, eye illumination should be identical to that used for mesopic contrast sensitivity testing. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 5 minutes). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
preoperative, 120-180 days postoperative
Title
Fundus examination with dilated pupil
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Fundus
Time Frame
preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - Corneal status
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Corneal Status
Time Frame
Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - Iris status
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: • Iris Status
Time Frame
Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - Signs of inflammation
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: Signs of inflammation Anterior chamber cells, Anterior chamber flare, Cystoid macular oedema, Hypopyon, and Endophthalmitis.
Time Frame
Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Slitlamp examination - Pupillary block
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - Pupillary block.
Time Frame
1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - Retinal detachment
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - Retinal detachment.
Time Frame
preoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - Status of anterior and posterior capsule
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - Status of anterior and posterior capsule.
Time Frame
1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - IOL decentration
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - IOL decentration.
Time Frame
1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - IOL tilt
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - IOL tilt.
Time Frame
1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - IOL discoloration
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - IOL discoloration.
Time Frame
1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Slitlamp examination - IOL opacity
Description
The slitlamp examination is one examination to analyse the integrity of eye structures and the implanted IOL. The examination is performed and documented according to the guidelines in ISO 11979-7:2018. With the slitlamp the ophthalmologist can observe the eyes stereoscopically. A focussed slit of light, which can be width-adjusted, is projected on the eye to be examined. The investigator observes this projection on the eye through a reflected light microscope. The slitlamp is used to observe the anterior and posterior part of the eye, including cornea, lens and anterior chamber. By dilating the pupil the fundus can also be examined. Following conditions shall be examined with the slitlamp: - IOL opacity.
Time Frame
1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Intraocular pressure (IOP) measurement
Description
The IOP will be measured with non-contact tonometer as part of the routine follow up examinations. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative, 330-420 days postoperative
Title
Keratometry
Description
Keratometric measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
IOL power and target refraction
Description
The parameter of the implanted IOL must be recorded as well as the target refraction given by the IOL calculator. This parameter is needed to calculate the accuracy of achieving the target refraction. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
day of surgery
Title
Fundus OCT
Description
An OCT (optical coherence tomography) image will be taken at the preoperative visit to identify AMD suspicious eyes that need to be excluded from this study. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
Biometry
Description
Biometry measurements are performed to calculate the required IOL power. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
Corneal topography
Description
Pentacam device (Oculus, Germany) will be used to perform corneal topography. This examination is needed to exclude patients showing an irregular corneal astigmatism.
Time Frame
Preoperative
Title
Corneal aberrometry
Description
Pentacam device (Oculus, Germany) will be used to perform corneal aberrometry measurement. The following values will be evaluated in this study: Spherical aberrations, high order aberrations.
Time Frame
Preoperative
Title
IOL rotation
Description
To determine the rotational stability of the lenses after implantation, the actual IOL orientation has to be recorded as the intended surgical position during surgery using a photograph through the surgery microscope or within one hour after surgery using a photograph through a slit lamp to document the rotational position of the IOL. Additional orientations are measured and recorded at the follow up visits by taking retroilluminated photographs in mydriasis using the slit lamp. To determine the rotational stability, it is important that the IOL axis marks of the IOL are visible as well as concurrent structures of the eye (in the same image) that are fixed and stable. Preferred fixed structures are limbal vessels. The pupil is dilated if necessary to visualize the IOL axis marks.
Time Frame
day of surgery, 1-2 days postoperative, 7-14 days postoperative, 30-60 days postoperative, 120-180 days postoperative
Title
Halo and glare scores
Description
A Halo and Glare simulator software (Eyeland Design Network GmbH, Germany) will be used to assess the subjective perception of photic phenomena. The patients will be asked to adjust the halo and glare level in a simulated image to the amount they perceive of such photic phenomena. This test is performed pre- and postoperatively. The preoperative outcomes serve as a baseline measurement.
Time Frame
Preoperative, 120-180 days postoperative, 330-420 days postoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinically documented age-related cataract in both eyes with no comorbidity; Calculated IOL power is within the range of the investigational IOLs; Male or female adults ages 50 years or older on the day of screening who have cataracts in both eyes; Regular corneal astigmatism (measured by topographer) Astigmatism ≤1.0 D (measured by an automatic keratometer) Clear intraocular media other than cataract; Availability, willingness and sufficient cognitive awareness to comply with examination procedures; Patient is willing to receive bilateral implantation of a trifocal IOL (this inclusion criteria applies only to the study group, not the control group); Signed informed consent. Exclusion Criteria: Age of patient < 50 years; Regular corneal astigmatism >1.0 dioptres (measured by an automatic keratometer) Irregular astigmatism (measured by topographer); Difficulty for cooperation (distance from their home, general health conditions); Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders); Subjects with AMD suspicious eyes as determined by OCT examination; Previous intraocular or corneal surgery; Traumatic cataract; Instability of keratometry or biometry measurements; Acceptable maximum standard deviation: AL: ± 150 µm; ACD: ± 150 µm; K1 / K2: ± 0.15 D; Ocular hypertension, suspicious glaucoma or glaucoma; Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions); Expected complicated surgery; Ocular surface disease (clinical symptoms or keratitis); Pregnancy or lactation; Second eye treatment will only be performed when Best Corrected Distance Visual Acuity (CDVA) of first eye is ≤ 0.2 logMAR (≥ 0.63 decimal); Concurrent participation in another drug or device investigation. In addition to above mentioned in- and exclusion criteria, subjects shall be discontinued when certain conditions are present at the time of surgery, including: zonular instability; need for iris manipulation; capsular fibrosis or other opacity; and inability to fixate IOL in desired position. In such cases, the subject shall be followed until the condition has stabilized.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jochen Kandulla, PhD
Phone
+49 176 55708170
Email
jochen.kandulla@targomed.de
First Name & Middle Initial & Last Name or Official Title & Degree
Line Bettinelli
Phone
+33 619 53 07 01
Email
line.bettinelli@cutting-edge.fr
Facility Information:
Facility Name
Gemini Eye Clinic Ostrava
City
Ostrava
ZIP/Postal Code
700 30
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Slovak
Phone
+420 730 873 183
Email
martin.slovak@gemini.cz
First Name & Middle Initial & Last Name & Degree
Simona Rakusanova
Phone
+420 730 873 184
Email
simona.rakusonova@gemini.cz
First Name & Middle Initial & Last Name & Degree
Dalibor Cholevik, MD
Facility Name
Gemini Eye Clinic Praha-Krc
City
Praha
ZIP/Postal Code
140 00
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Slovak
Phone
+420 730 873 183
Email
martin.slovak@gemini.cz
First Name & Middle Initial & Last Name & Degree
Simona Rakusanova
Phone
+420 730 873 184
Email
simona.rakusonova@gemini.cz
First Name & Middle Initial & Last Name & Degree
Drahomira Barakova, MD
Facility Name
Gemini Eye Clinic Zlín
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Martin Slovak
Phone
+420 730 873 183
Email
martin.slovak@gemini.cz
First Name & Middle Initial & Last Name & Degree
Simona Rakusanova
Phone
+420 730 873 184
Email
simona.rakusonova@gemini.cz
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka, MD
Facility Name
Hospital Donostia
City
Donostia San Sebastian
ZIP/Postal Code
20014
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Iraia Reparaz Bonilla
Phone
(+34) 676 52 96 84
Email
IRAIA.REPARAZ@biodonostia.org
First Name & Middle Initial & Last Name & Degree
Javier Medicute del Barrio, MD
Facility Name
Oftalvist Madrid
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arturo Corroto
Email
acorroto@oftalvist.es
First Name & Middle Initial & Last Name & Degree
Enrique Artiaga, MD
First Name & Middle Initial & Last Name & Degree
Marta Ibarz, MD
First Name & Middle Initial & Last Name & Degree
Marceliano Crespo, MD
Facility Name
Hospital Universitario Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuria Garzón Jiménez, PhD
Phone
(+34) 659 057 151
Email
mgarzonj@ucm.es
First Name & Middle Initial & Last Name & Degree
Celia Villanueva
Phone
(+34) 91 330 39 00
Email
celia.villanueva.hcsc@gmail.com
First Name & Middle Initial & Last Name & Degree
Javier García Bella, MD
Facility Name
Hospital Miguel Servet
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marta Jiménez
Phone
(+34) 976 76 55 58
Email
mjimenez@iisaragon.es
First Name & Middle Initial & Last Name & Degree
Irene Altemir
Phone
(+34) 976 76 55 58
Email
irealtemir@gmail.com
First Name & Middle Initial & Last Name & Degree
Luis Pablo Júlvez, MD
First Name & Middle Initial & Last Name & Degree
José M Larrosa, MD
First Name & Middle Initial & Last Name & Degree
Francisco J Castro, MD
First Name & Middle Initial & Last Name & Degree
Vicente Polo, MD
First Name & Middle Initial & Last Name & Degree
Antonio J Mateo Orobia, MD
First Name & Middle Initial & Last Name & Degree
Martin Puzo Bayod, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
20505205
Citation
McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.
Results Reference
background
PubMed Identifier
28341605
Citation
Morlock R, Wirth RJ, Tally SR, Garufis C, Heichel CWD. Patient-Reported Spectacle Independence Questionnaire (PRSIQ): Development and Validation. Am J Ophthalmol. 2017 Jun;178:101-114. doi: 10.1016/j.ajo.2017.03.018. Epub 2017 Mar 22.
Results Reference
background
PubMed Identifier
19251145
Citation
Lundstrom M, Pesudovs K. Catquest-9SF patient outcomes questionnaire: nine-item short-form Rasch-scaled revision of the Catquest questionnaire. J Cataract Refract Surg. 2009 Mar;35(3):504-13. doi: 10.1016/j.jcrs.2008.11.038.
Results Reference
background

Learn more about this trial

Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens

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