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

Last updated: May 22, 2025
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Cataracts

Eye Disorders/infections

Eye Disease

Treatment

Model ZCB00/DCB00

Model C0002

Clinical Study ID

NCT05531292
PCOL106APV2
  • Ages 60-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age of study population between 60-75 years;

  2. Bilateral cataracts for which cataract extraction and posterior chamber IOLimplantation have been planned for both eyes;

  3. 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 aglare source present (e.g., Brightness Acuity Tester) or with significant cataractrelated visual symptoms in the opinion of the investigator;

  4. Potential postoperative best-corrected distance visual acuity (BCDVA) of 0.66decimal (6/9 or 20/30 Snellen) or better;

  5. Drives a car at least 1-2 times per month;

  6. Corneal astigmatism:

  7. Normal corneal topography

  8. Predicted postoperative residual refractive cylinder based on a toric IOLcalculator, taking surgically induced astigmatism (SIA) into account and usingthe posterior corneal astigmatism (PCA) option, must be less than 1.00 D inboth eyes.

  9. Clear intraocular media other than cataract in each eye;

  10. Availability, willingness, sufficient cognitive awareness to comply with examinationprocedures;

  11. Signed informed consent and HIPAA authorization or equivalent documentationnecessary to comply with applicable privacy laws pertaining to medical treatment inthe governing countries;

  12. Ability to understand, read, and write in French.

Exclusion

Exclusion Criteria:

  1. Requiring an intraocular lens power needed to achieve emmetropia (sphericalequivalent ± 0.50 D) outside the available range of +18.0 D to +30.0 D for the ModelC0002 IOL or +16.5 D to +27.5 D for the Model ZCB00 IOL;

  2. Pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils);

  3. Irregular corneal astigmatism;

  4. Recent ocular trauma or ocular surgery that is not resolved/stable or may affectvisual outcomes or increase risk to the subject;

  5. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery;

  6. Subjects who may be expected to require retinal laser treatment during the study;

  7. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies thatare predicted to cause visual acuity losses to a level of worse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;

  8. Inability to achieve keratometric corneal stability preoperatively as a result ofrecent contact lens usage;

  9. Subjects with diagnosed degenerative visual disorders (e.g., retinal disorders suchas macular degeneration) that are predicted to cause visual acuity losses to a levelworse than 0.66 decimal (6/9 or 20/30 Snellen) during the study;

  10. Subjects with conditions associated with increased risk of zonular rupture,including capsular or zonular abnormalities that may lead to IOL decentration ortilt, such as pseudoexfoliation, trauma, or posterior capsule defects;

  11. Use of systemic or ocular medications that may affect vision;

  12. Prior, current, or anticipated use during the course of the study of tamsulosin orsilodosin (e.g., Flomax, Flomaxtra, Rapaflo) that may, in the opinion of theinvestigator, confound the outcomes or increase the risk to the subject (e.g., poordilation or a lack of adequate iris structure to perform standard cataract surgery);

  13. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus,nystagmus, etc.);

  14. Poorly-controlled diabetes;

  15. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in theopinion of the investigator, would increase the operative risk or confound theoutcomes of the study (e.g., immunocompromised, connective tissue disease, suspectedglaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation,etc.); NOTE: Controlled ocular hypertension without glaucomatous changes (opticnerve cupping and visual field loss) is acceptable.

  16. Neurological or neurodegenerative disorders that affect locomotion and cognitivefunction (e.g., Muscular disorders, Parkinson's disease, Alzheimer's disease etc.);

  17. Use of mobility aids, any injury or condition that may affect walking;

  18. Subject has condition(s) associated with the fluctuation of hormones that could leadto refractive changes;

  19. Concurrent participation in any other clinical trial or participation within 30 daysprior to the preoperative visit.

Study Design

Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Model ZCB00/DCB00
Phase:
Study Start date:
November 22, 2022
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • Centre Hospitalier National d'Ophtalmologie

    Paris, Ile-de-France 75012
    France

    Site Not Available

  • Rothschild Foundation Hospital

    Paris, Ile-de-France 75019
    France

    Site Not Available

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