Back to resultsComparison of ISOPURE and EYHANCE (Switzerland) (PHY2301)
Primary Purpose
Cataract, Lens Opacities
Status
Not yet recruiting
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
IOL implantation experimental (ISOPURE 1.2.3.)
IOL implantation active comparator (TECNIS Eyhance)
Sponsored by
About this trial
This is an interventional treatment trial for Cataract focused on measuring Intraocular Lens, EDOF, hydrophobic, IOL
Eligibility Criteria
Inclusion Criteria: Cataractous eyes with no comorbidity; Calculated IOL power is within the range of the study IOLs; Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes; Regular total corneal astigmatism ≤1.0 D (measured by topography method) Clear intraocular media other than cataract; Availability, willingness and sufficient cognitive awareness to comply with examination procedures; Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR; Signed informed consent. Exclusion Criteria: Age of patient < 50 years; Regular total corneal astigmatism >1.0 dioptres (measured by topography method) Irregular astigmatism; 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 who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker; previous laser treatment for peripheral retinal tears is allowed; Previous intraocular or corneal surgery or intravitreal injection; Traumatic cataract; History or presence of macular edema; Glaucoma with visual field defects; or RNFL defects on OCT; ocular hypertension is allowed; Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions); Amblyopia with monocular preoperative CDVA of >0.1 logMAR; Cornea guttata; Keratoconus; Chronic uveitis; Expected complicated surgery; Significant dry eye; Contra-indications as listed in the current Instructions for use (IFU); Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery; Concurrent or previous (within 60 days) 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 or defect; 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
- Eye center Vista Alpina
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: Premium monofocal intraocular lens.
Comparator arm: EDOF intraocular lens.
Outcomes
Primary Outcome Measures
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Non inferiority of ISOPURE 1.2.3. outcomes compared to the TECNIS Eyehance outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance.
A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
Secondary Outcome Measures
Safety (Rates of Adverse Events)
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2)
Full Information
NCT ID
NCT05875922
First Posted
May 5, 2023
Last Updated
August 1, 2023
Sponsor
Beaver-Visitec International, Inc.
Collaborators
targomedGmbH
1. Study Identification
Unique Protocol Identification Number
NCT05875922
Brief Title
Comparison of ISOPURE and EYHANCE (Switzerland)
Acronym
PHY2301
Official Title
Prospective Post-Market Clinical Follow-Up (PMCF) Study to Investigate the Clinical Outcomes of a ISOPURE and EYHANCE Intraocular Lenses (IOL)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
February 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Beaver-Visitec International, Inc.
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
This is a prospective randomised open-label study with the aim to compare the visual performance of the premium monofocal Isopure IOL versus the extended depth of focus Eyhance® IOL after phaco-emulsification cataract surgery.
Detailed Description
This is a single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study whereby patients undergoing routine cataract surgery will have bilateral implantation of premium monofocal intraocular lenses (PhysIOL ISOPURE 1.2.3.) or EDOF lenses (TECNIS Eyhance). The patients will be randomized in a 1:1 ratio to receive the study or control lenses. Both IOLs, investigational device and control device, are CE approved and commercially available in the countries this clinical investigation is being carried out. The investigational device 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 device under investigation (ISOPURE 1.2.3.) is a hydrophobic, glistening-free, acrylic premium monofocal intraocular lens (IOL) manufactured by the sponsor of this study, PhysIOL sa/nv. The control lens (TECNIS Eyhance) is a non-diffractive Extended Vision Posterior Chamber IOL.
The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.
Subjects participating in the trial will attend a total of 6 study visits (1 preoperative, 1 operative and 4 postoperative) over a period of 6 months. Subjects would have the option for unscheduled visits if required medically.
Primary and secondary endpoint data will be collected at the 120-180 days follow up visit.
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, EDOF, hydrophobic, IOL
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
Double-blind masking; Patient will not be informed which IOL model was implanted until end of the study. Outcomes assessors will not be informed which IOL model was implanted until end of the study.
Allocation
Randomized
Enrollment
68 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IOL implantation experimental
Arm Type
Experimental
Arm Description
Experimental arm: Premium monofocal intraocular lens.
Arm Title
IOL implantation active comparator
Arm Type
Active Comparator
Arm Description
Comparator arm: EDOF intraocular lens.
Intervention Type
Device
Intervention Name(s)
IOL implantation experimental (ISOPURE 1.2.3.)
Intervention Description
Implantation of premium monofocal IOL ISOPURE 1.2.3.
Intervention Type
Device
Intervention Name(s)
IOL implantation active comparator (TECNIS Eyhance)
Intervention Description
Implantation of EDOF IOL TECNIS Eyhance
Primary Outcome Measure Information:
Title
monocular Best Corrected Distance Visual Acuity (CDVA) under photopic light conditions on the first implanted eye.
Description
Non inferiority of ISOPURE 1.2.3. outcomes compared to the TECNIS Eyehance outcomes in terms of monocular Best Corrected Distance Visual Acuity (CDVA) by means of statistical significance.
A significance level of 0.05 or lower (p < 0.05) will be considered statistically significant. CDVA is measured with ETDRS charts placed in 4m distance with best aided corrective glasses according to ISO 11979-7:2018.
Time Frame
6 months (120-180 days) postoperative
Secondary Outcome Measure Information:
Title
Safety (Rates of Adverse Events)
Description
The objective is to compare the SPE (Safety and Performance Endpoints) rates of the investigational product to the results of historical data of EN ISO 11979-7:2018, Annex E (Table E.2)
Time Frame
1 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Other Pre-specified Outcome Measures:
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 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Anterior Chamber Depth
Description
Anterior Chamber Depth measurement is performed using the IOLMaster device. This measurement is required to calculate the required IOL power. The measurement unit is mm. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
Axial Lenght
Description
Axial Length measurement is performed using the IOLMaster device. This measurement is required to calculate the required IOL power. The measurement unit is mm. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
Lens Thickness
Description
Lens Thickness measurement is performed using the IOLMaster device to asses the dimension of the natural lnes. This measurement is required to calculate the required IOL power. The measurement unit is mm. The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
Keratometry measurement - K values
Description
Keratometric measurements are performed to calculate the required IOL power. The measurement is performed using the IOLMaster device. This specific outcome measure is to measure the K value in the steep axis (K1) and flat axis (K2). The measurement unit is diopter (D). The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
Preoperative
Title
IOL power
Description
The IOL spherical power of the implanted IOL must be recorded.
Time Frame
Operative (day of surgery)
Title
Target refraction
Description
The target refraction given by the IOL calculator must be recorded. 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
Operative (day of surgery)
Title
Fundus OCT
Description
An OCT (optical coherence tomography) image will be taken at the preoperative visit and 1 months postoperative 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, 1 month (30-60 days) postoperative
Title
Pupil Size under mesopic light conditions
Description
Mesopic pupil diameters are measured with 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. It is required that pupil measurements be made with an infrared pupillometer / CCD camera. Pupil measurements should only be made after the eye has had time to fully adapt to the testing conditions (at least 10 minutes).
The examination is performed and documented according to the guidelines in ISO 11979-7:2018.
Time Frame
preoperative
Title
Manifested refraction
Description
The manifested 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 manifested refractive spherical equivalent (MRSE)
Time Frame
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Monocular Uncorrected Distance Visual Acuity (UDVA) under photopic light conditions
Description
monocular and binocular 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 day (1-2 days) postoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (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
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Binocular Uncorrected Distance Visual Acuity (UDVA) under mesopic 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 mesopic light conditions.
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 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, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (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
6 months (120-180 days) postoperative
Title
Monocular Distance Corrected Intermediate Visual Acuity at 66cm (DCIVA@66cm) under photopic light conditions
Description
Monocular DCIVA@66cm 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
1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Binocular Uncorrected Intermediate Visual Acuity at 66cm (UIVA@66cm) under mesopic light condition
Description
Binocular UIVA@66cm is measured with ETDRS charts placed in 66cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under mesopic light conditions.
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Monocular Distance Corrected Near Visual Acuity at 40cm (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
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Binocular Uncorrected Near Visual Acuity at 40cm (UNVA) under photopic light conditions
Description
Monocular UNVA is measured with ETDRS charts placed in 40cm distance. The examination is done without corrective glasses and according to ISO 11979-7:2018. This assessment is done binocularly under photopic light conditions.
Time Frame
1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (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 -2.5 D to +1.5 D in 0.5 D steps. This examination is performed binocularly.
Time Frame
1 month (30-60 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 (Vector Vision). This examination is performed binocularly.
Time Frame
6 months (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 (Vector Vision). This examination is performed binocularly.
Time Frame
6 months (120-180 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 month (30-60 days) postoperative, 6 months (120-180 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
Time Frame
Preoperative, 1 month (30-60 days) postoperative, 6 months (120-180 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 month (30-60 days) postoperative, 6 months (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, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Slitlamp examination - Optic nerve cupping
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:
- Optic nerve cupping
Time Frame
Preoperative, 1 week (7-14 days) postoperative, 1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative, 12 months (330-420 days) postoperative
Title
Slitlamp examination - Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis
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:
- Posterior Capsular Opacification (PCO) or Posterior Capsular Fibrosis
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 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
6 months (120-180 days) postoperative
Title
Slitlamp examination - abnormal IOL positioning
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:
- abnormal IOL positioning
Time Frame
1 month (30-60 days) postoperative, 6 months (120-180 days) postoperative
Title
Patient reported outcomes - Quality of Vision questionnaire
Description
To assess the subjective perception of disturbances by photic phenomena. Subjects answer one question per category on their individual perception of glare, halo and starbursts, respectively. Answers are graded in 5 steps between always and never.
Descriptive analysis will be performed on the occurence of photic phenomena per category. This questionnaire does not consist of a scaling.
Time Frame
6 months (120-180 days) postoperative
Title
Patient reported outcomes - Patient-Reported Spectacle Independence Questionnaire (PRSIQ) [Morlock et al, 2017]
Description
The Patient-Reported Spectacle Independence Questionnaire (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].
In the first category, subjects are asked if they need glasses for distance vision, intermediate vision and near vision with 'yes' and 'no' being the only possible answers.
In the second category, patients are asked to scale their frequency of using spectacles over the last 7 days for three different distances with 5 ratings ranging from '1: All of the time' to '5: None of the time'. A higher rating means higher rate of spectacle independence.
In addition, patients are asked to scale if they are able to function without spectacle aid for three different distances with 5 ratings ranging from '1: All of the time' to '5: None of the time'. A higher rating means higher rate of spectacle freedom.
Time Frame
6 months (120-180 days) postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Cataractous eyes with no comorbidity;
Calculated IOL power is within the range of the study IOLs;
Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
Regular total corneal astigmatism ≤1.0 D (measured by topography method)
Clear intraocular media other than cataract;
Availability, willingness and sufficient cognitive awareness to comply with examination procedures;
Expected postoperative Best Corrected Distance Visual Acuity (CDVA) ≤ 0.2 logMAR;
Signed informed consent.
Exclusion Criteria:
Age of patient < 50 years;
Regular total corneal astigmatism >1.0 dioptres (measured by topography method)
Irregular astigmatism;
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 who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema or macula pucker; previous laser treatment for peripheral retinal tears is allowed;
Previous intraocular or corneal surgery or intravitreal injection;
Traumatic cataract;
History or presence of macular edema;
Glaucoma with visual field defects; or RNFL defects on OCT; ocular hypertension is allowed;
Pupil abnormalities (non-reactive, tonic pupils, abnormally shaped pupils or pupils that do not dilate under mesopic / scotopic conditions);
Amblyopia with monocular preoperative CDVA of >0.1 logMAR;
Cornea guttata;
Keratoconus;
Chronic uveitis;
Expected complicated surgery;
Significant dry eye;
Contra-indications as listed in the current Instructions for use (IFU);
Contra-indication or unwillingness to perform immediate sequential bilateral cataract surgery;
Concurrent or previous (within 60 days) 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 or defect;
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
Rebecca McQuaid, PhD
Phone
+353 87 1212615
Email
r.mcquaid@physiol.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristof Vandekerkchove, MD
Organizational Affiliation
Eye center Vista Alpina
Official's Role
Principal Investigator
Facility Information:
Facility Name
Eye center Vista Alpina
City
Visp
ZIP/Postal Code
3930
Country
Switzerland
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kristof Vandekerckhove, MD
Email
vandekerckhove@vista-alpina.ch
First Name & Middle Initial & Last Name & Degree
Kristof Vandekerckhove, MD
First Name & Middle Initial & Last Name & Degree
Dimitri Baeriswyl, MD
First Name & Middle Initial & Last Name & Degree
Nikola Tomagova, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
37007049
Citation
Tomagova N, Elahi S, Vandekerckhove K. Clinical Outcomes of a New Non-Diffractive Extended Depth-of-Focus Intraocular Lens Targeted for Mini-Monovision. Clin Ophthalmol. 2023 Mar 25;17:981-990. doi: 10.2147/OPTH.S405267. eCollection 2023.
Results Reference
background
PubMed Identifier
32932369
Citation
Auffarth GU, Gerl M, Tsai L, Janakiraman DP, Jackson B, Alarcon A, Dick HB; Quantum Study Group. Clinical evaluation of a new monofocal IOL with enhanced intermediate function in patients with cataract. J Cataract Refract Surg. 2021 Feb 1;47(2):184-191. doi: 10.1097/j.jcrs.0000000000000399.
Results Reference
background
PubMed Identifier
35947003
Citation
Wan KH, Au ACK, Kua WN, Ng ALK, Cheng GPM, Lam NM, Chow VWS. Enhanced Monofocal Versus Conventional Monofocal Intraocular Lens in Cataract Surgery: A Meta-analysis. J Refract Surg. 2022 Aug;38(8):538-546. doi: 10.3928/1081597X-20220707-01. Epub 2022 Aug 1.
Results Reference
background
Learn more about this trial
Comparison of ISOPURE and EYHANCE (Switzerland)
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