Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants

Clinical Evaluation of Low Contrast Defocus Curves, Low Light Photic Phenomena, and Dysphotopsia Profiles in Pseudophakic Patients

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

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 IOLs.

The primary endpoints are low (50%) contrast defocus curve, halometry (cool white light) assessment of photic phenomena, and PRVSQv2 results.

The secondary endpoints are:

• Visual Acuity
• BCDVA
• Low contrast (50%) BCDVA
• Contrast Sensitivity
• High contrast defocus curve
• Halometry:
• Light levels: low, medium, high
• Colors: cool white, warm white, red, green
• Characterization of glare, starbursts, and halos
• PRO questionnaires
• AIOLIS
• Patient satisfaction and recommendation survey
• Pupil size
• YAG capsulotomy within 1 year
• Posterior capsular opacification: pre-planned post-hoc analysis evaluating performance in patients w/wo PCO Monocular BCDVA

Participants will:

• Complete PRVSQ v2 and AIOLIS vision questionnaires in a randomized order.
• Undergo the following visual testing using M&S, clinical halometry, and the manifold vision meter devices:
• Manifest refraction
• Distance visual acuity
• Defocus testing
• Low contrast testing
• Contrast sensitivity
• Pupilometry
• Halometry
• Biomicroscopic slit-lamp exam
• Intraocular pressure
• Non-directed ocular symptoms

Inclusion Criteria:

• 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 Criteria:

• 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