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Recruiting NCT07213167

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

— Observational Dysphotopsia Posterior Capsule Opacification Visual Acuity Visual Function

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: None-placebo.
Who it may be relevant to
Registry conditions: Dysphotopsia, Posterior Capsule Opacification, Visual Acuity, Visual Function. Basic parameters: from 22 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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 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

Interventions

  • Other None-placebo
    No interventions.

Primary outcome measures

  • Low (50%) contrast defocus curve [Time frame: Day 1]
  • Halometry assessment of photic phenomena [Time frame: Day 1]
  • PRVSQv2 questionnaire results [Time frame: Day 1]
Secondary outcome measures (9)
  • Best corrected distance visual acuity (BCDVA) [Time frame: Day 1]
  • Low contrast (50%) BCDVA [Time frame: Day 1]
  • Contrast Sensitivity [Time frame: Day 1]
  • High Contrast Defocus Curve [Time frame: Day 1]
  • Halometry [Time frame: Day 1]
  • Patient-Reported Outcome (PRO) Questionnaires [Time frame: Day 1]
  • Pupil Size [Time frame: Day 1]
  • YAG Capsulotomies [Time frame: Day 1]
  • Posterior capsular opacification (PCO) [Time frame: Day 1]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

United States · 1 center
  • Empire Eye and Laser Center — Bakersfield

Identifiers

NCT: NCT07213167 · EMP-2025-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗