PROOF-OF-CONCEPT STUDY FOR NEW INTRAOCULAR LENS, MODEL C0002

Johnson & Johnson Surgical Vision, Inc.2 sites in 1 country106 target enrollmentNovember 22, 2022

ConditionsCataracts

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Cataracts
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Enrollment: 106
Locations: 2
Primary Endpoint: MONOCULAR, PHOTOPIC BCDVA AT 4 M
Status: Completed
Last Updated: 9 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

Prospective, two-arm, randomized, bilateral, subject/evaluator-masked clinical study to evaluate the distance visual acuity, peripheral refractive error and functional vision of the EPV IOL compared to a standard monofocal control IOL.

Registry

clinicaltrials.gov

Start Date

November 22, 2022

End Date

May 20, 2025

Last Updated

9 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 C0002 IOL or +16.5 D to +27.5 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;