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

Dr. Daniel H. Chang, MD

Status

Enrolling

Conditions

Posterior Capsule Opacification

Visual Function

Dysphotopsia

Contrast Sensitivity

Visual Acuity

Treatments

Other: None-placebo

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT07213167

EMP-2025-001

Details and patient eligibility

About

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

Full 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 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

Enrollment

120 estimated patients

Sex

All

Ages

22+ years old

Volunteers

No Healthy Volunteers

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