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 intraocular lens (IOL) implants after cataract surgery.
Researchers will compare the results for three different types of IOLs to see how each lens contributes to overall visual function, patient experience and satisfaction.
Participants will:
* Complete two different questionnaires about their current vision * Undergo visual testing using several different devices
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
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.
Bilateral pseudophakia, at least 3 months postoperative from IOL implantation with one of the study IOL models.
Case-only
Prospective
None-placebo
Other interventionNo interventions, only post-market, post-implantation observation.
Low (50%) contrast defocus curve
Measured low (50%) contrast defocus curve compared between all three groups
Halometry assessment of photic phenomena
Halometry assessment of halos and starbursts utilizing a cool white light with varying intensities. Comparing the measured size of the ring (deg) of each condition between all three groups.
PRVSQv2 questionnaire results
PRVSQv2 questionnaire results compared between all three groups: Frequency and bother/severity of symptoms (scale 1 to 5, with 5 most bothersome)
Best corrected distance visual acuity (BCDVA)
Best corrected distance visual acuity (BCDVA) compared between all three groups
Low contrast (50%) BCDVA
Low contrast (50%) BCDVA compared between all three groups
Contrast Sensitivity
Contrast sensitivity compared between all three groups
High Contrast Defocus Curve
High Contrast Defocus Curve compared between all three groups
Click on the lead sponsor to view all of their trials.
Dr. Daniel H. Chang, MD
Lead sponsor
Empire Eye and Laser Center
Sponsor institution
Johnson & Johnson Surgical Vision, Inc.
Collaborator
