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Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs (LuxSmart)

Primary Purpose

Cataract Senile

Status
Completed
Phase
Not Applicable
Locations
Czechia
Study Type
Interventional
Intervention
Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes
Sponsored by
Gemini Eye Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract Senile

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
  • Clear intraocular media other than cataract;
  • Dilated pupil size large enough to visualize IOL axis markings postoperatively
  • Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
  • Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.

Exclusion Criteria:

  • Age of patient <50 years;
  • Regular corneal astigmatism >1.5D (measured by an automatic keratometry) in both eyes;
  • Irregular astigmatism;
  • Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
  • Subjects with AMD suspicious eyes as determined by OCT examination;
  • 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;
  • Previous intraocular or corneal surgery;
  • Traumatic cataract;
  • History or presence of macular edema;
  • Instability of keratometry or biometry measurements;
  • Advanced or decompensated glaucoma;
  • Significant dry eye;

Sites / Locations

  • Gemini Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Bilateral implantation of LuxSmart hydrophobic IOL

Arm Description

Cataract surgery will be carried out using standard phacoemulsification technique with a 2.2 mm incision. Investigators will target a 5.5 mm diameter capsulorhexis to allow the optic to be fully overlapped by the anterior capsular rim. The intended target of the post-operative refraction will be emmetropia. The patient will be implanted with LuxSmart hydrophobic IOLs in both eyes and followed up for 6 months

Outcomes

Primary Outcome Measures

Corrected Distance Visual Acuity
Measurement of distance visual acuity is measured with 5 letters modified Snellen charts placed at 6 m distance with corrective glasses for each eye separately

Secondary Outcome Measures

Manifest refraction (sphere, cylinder, axis)
Standard refraction technique
Monocular Uncorrected Distance Visual Acuity (UDVA)
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for each eye separately
Binocular Uncorrected Distance Visual Acuity (UDVA)
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for both eyes together
Monocular Corrected Distance Visual Acuity (CDVA)
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for each eye separately
Binocular Corrected Distance Visual Acuity (CDVA)
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for both eyes together
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Monocular Defocus Curve
Standard defocus curve with -5.0 to +1.5 D range lenses
Monocular Contrast Sensitivity under photopic and mesopic conditions
Measurement of contrast sensitivity at 2.5 m
Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score
To assess if difficulties in daily life occur due to impaired sight. This questionnaire is 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery. There are five text response options for the answers scaled from "Yes, very great difficulties" to "No, no difficulties" including answer "Cannot decide". Outcome is a sum score (min: 9, max: 36, lower scores mean a better result)
Overall Spectacle independence
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ - "a little of the time" or "none of the time".

Full Information

First Posted
August 19, 2020
Last Updated
April 16, 2023
Sponsor
Gemini Eye Clinic
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1. Study Identification

Unique Protocol Identification Number
NCT04523558
Brief Title
Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs
Acronym
LuxSmart
Official Title
Evaluation of the Extended Depth of Focus After Bilateral Implantation of a Hydrophobic IOL With a New Optic Concept Based on a Combination of High Order Aberrations
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
June 25, 2020 (Actual)
Primary Completion Date
April 1, 2021 (Actual)
Study Completion Date
April 8, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gemini Eye Clinic

4. Oversight

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

5. Study Description

Brief Summary
This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch & Lomb). The device under investigation is CE-mark approved and commercially available. The device under investigation 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. Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past. The device under investigation LuxSmart (Bausch & Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development. In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract Senile

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bilateral implantation of LuxSmart hydrophobic IOL
Arm Type
Experimental
Arm Description
Cataract surgery will be carried out using standard phacoemulsification technique with a 2.2 mm incision. Investigators will target a 5.5 mm diameter capsulorhexis to allow the optic to be fully overlapped by the anterior capsular rim. The intended target of the post-operative refraction will be emmetropia. The patient will be implanted with LuxSmart hydrophobic IOLs in both eyes and followed up for 6 months
Intervention Type
Device
Intervention Name(s)
Implantation of LuxSmart hydrophobic IOLs (Bausch + Lomb) in both eyes
Intervention Description
Extended depth of field intraocular lens made form hydrophobic material
Primary Outcome Measure Information:
Title
Corrected Distance Visual Acuity
Description
Measurement of distance visual acuity is measured with 5 letters modified Snellen charts placed at 6 m distance with corrective glasses for each eye separately
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Manifest refraction (sphere, cylinder, axis)
Description
Standard refraction technique
Time Frame
6 months
Title
Monocular Uncorrected Distance Visual Acuity (UDVA)
Description
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for each eye separately
Time Frame
6 months
Title
Binocular Uncorrected Distance Visual Acuity (UDVA)
Description
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance without corrective glasses for both eyes together
Time Frame
6 months
Title
Monocular Corrected Distance Visual Acuity (CDVA)
Description
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for each eye separately
Time Frame
6 months
Title
Binocular Corrected Distance Visual Acuity (CDVA)
Description
Measurement of distance visual acuity is measured with 5 letter modified snellen charts placed at 6 m distance with corrective glasses for both eyes together
Time Frame
6 months
Title
Monocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Time Frame
6 months
Title
Binocular Uncorrected Intermediate Visual Acuity (UIVA)
Description
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Time Frame
6 months
Title
Monocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Description
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for one eye
Time Frame
6 months
Title
Binocular Distance Corrected Intermediate Visual Acuity (DCIVA)
Description
Measurement performed using ETDRS chart at 66 cm and 80 cm distance for both eyes
Time Frame
6 months
Title
Monocular Defocus Curve
Description
Standard defocus curve with -5.0 to +1.5 D range lenses
Time Frame
6 months
Title
Monocular Contrast Sensitivity under photopic and mesopic conditions
Description
Measurement of contrast sensitivity at 2.5 m
Time Frame
6 months
Title
Change in the 9-item Catquest short-form questionnaire (Catquest-9SF) score
Description
To assess if difficulties in daily life occur due to impaired sight. This questionnaire is 9-item Rasch-scaled instrument to assess subjective perception of visual impairment after surgery. There are five text response options for the answers scaled from "Yes, very great difficulties" to "No, no difficulties" including answer "Cannot decide". Outcome is a sum score (min: 9, max: 36, lower scores mean a better result)
Time Frame
6 months
Title
Overall Spectacle independence
Description
Percent of all patients who never or rarely wear spectacles for distance, intermediate or near vision 3 months postop (based on the Patient-Reported Spectacle Independence Questionnaire, or PRSIQ - "a little of the time" or "none of the time".
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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 corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes; Clear intraocular media other than cataract; Dilated pupil size large enough to visualize IOL axis markings postoperatively Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits. Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations. Exclusion Criteria: Age of patient <50 years; Regular corneal astigmatism >1.5D (measured by an automatic keratometry) in both eyes; Irregular astigmatism; Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse; Subjects with AMD suspicious eyes as determined by OCT examination; 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; Previous intraocular or corneal surgery; Traumatic cataract; History or presence of macular edema; Instability of keratometry or biometry measurements; Advanced or decompensated glaucoma; Significant dry eye;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pavel Stodulka
Organizational Affiliation
Gemini Eye Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Gemini Eye Clinic
City
Zlín
ZIP/Postal Code
760 01
Country
Czechia

12. IPD Sharing Statement

Plan to Share IPD
No

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Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs

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