Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT07213167
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 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
Study:
NCT07213167
Study Brief:
Protocol Section:
NCT07213167