Proof-of-concept Study for a New Intraocular Lens, MODEL C0001

Johnson & Johnson Surgical Vision, Inc.2 sites in 1 country113 target enrollmentNovember 18, 2021

ConditionsCataract

Overview

Phase: N/A
Intervention: Not specified
Conditions: Cataract
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Enrollment: 113
Locations: 2
Primary Endpoint: MONOCULAR, PHOTOPIC BCDVA AT 4 M
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study is a 12-month, prospective, 2-arm (1 test & 1 control), randomized (1 test:1 control), bilateral, subject/evaluator-masked clinical investigation of the EPV IOL versus the standard TECNIS monofocal control IOL.

The study will be conducted at a minimum of one to a maximum of five sites in France, with a total of 40 evaluable subjects for the investigational lens group and 40 evaluable subjects for the control lens group participating in the sub-study. The peripheral and functional testing will be conducted on a sub-group of subjects who achieve binocular uncorrected distance visual acuity (UCDVA) of 0.2 logMAR or better and/or are able to perform the driving simulator-sickness testing as determined by patient response to the SSQ (Appendix D) at the first 1-month visit.

The eye implanted first will be considered the primary study eye (first eye). Subjects will be randomized to either the investigational IOL Model C0001 or the control IOL Model ZCB00 in both eyes.

Registry

clinicaltrials.gov

Start Date

November 18, 2021

End Date

April 24, 2024

Last Updated

11 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age of study population between 60-75 years;
•Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned for both eyes;
•Cataractous lens changes, as demonstrated by best-corrected distance visual acuity (BCDVA) of 0.50 decimal or worse (6/12 or 20/40 Snellen) either with or without a glare source present (e.g., Brightness Acuity Tester) or with significant cataract-related visual symptoms in the opinion of the investigator;
•Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66 decimal (6/9 or 20/30 Snellen) or better;
•Drives a car at least 1-2 times per month;
•Corneal astigmatism:
•Normal corneal topography
•Predicted postoperative residual refractive cylinder based on a toric IOL calculator, taking surgically induced astigmatism (SIA) into account and using the posterior corneal astigmatism (PCA) option, must be less than 1.00 D in both eyes.
•Clear intraocular media other than cataract in each eye;
•Availability, willingness, sufficient cognitive awareness to comply with examination procedures;

Exclusion Criteria

•Requiring an intraocular lens power needed to achieve emmetropia (spherical equivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the Model C0001 IOL or +16.0 D to +28.0 D for the Model ZCB00 IOL;
•Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);
•Irregular corneal astigmatism;
•Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject;
•Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;
•Subjects who may be expected to require retinal laser treatment during the study;
•Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level of worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
•Inability to achieve keratometric corneal stability preoperatively as a result of recent contact lens usage;
•Subjects with diagnosed degenerative visual disorders (e.g., retinal disorders such as macular degeneration) that are predicted to cause visual acuity losses to a level worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;
•Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects;