Status:
RECRUITING
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Lead Sponsor:
Dr. Daniel H. Chang, MD
Collaborating Sponsors:
Johnson & Johnson Surgical Vision, Inc.
Conditions:
Dysphotopsia
Posterior Capsule Opacification
Eligibility:
All Genders
22+ years
Brief Summary
The goal of this clinical investigation is to evaluate visual acuity and contrast sensitivity in low lighting conditions using several different testing devices, and measure nighttime side effects of ...
Detailed Description
The purpose of the study is to correlate the low contrast defocus curves, objective halometry measurement of low light photic phenomena, and patient reported dysphotopsia profiles of the various study...
Eligibility Criteria
Inclusion
- Minimum 22 years of age
- Bilateral pseudophakia, at least 3 months postoperative from IOL implantation, with one of the study IOL models in at least one eye.
- Availability, willingness, and sufficient cognitive awareness to comply with examination procedures
- Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
- Ability to understand and respond to a questionnaire in English
Exclusion
- Any clinically significant pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils.
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
- Uncorrected distance visual acuity worse than 20/25 in either eye
- Prior corneal refractive surgery (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcomes are acceptable.
- Posterior capsular opacification with grading worse than 1+
- Ocular findings that may, in the opinion of the investigator, affect vision and/or contrast sensitivity
Key Trial Info
Start Date :
September 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT07213167
Start Date
September 24 2025
End Date
March 1 2026
Last Update
October 8 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Empire Eye and Laser Center
Bakersfield, California, United States, 93309