Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT07213167
Status:
RECRUITING
Last Update Posted:
2025-10-08
First Post:
2025-09-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Clinical Evaluation of Low Contrast Visual Performance and Low Light Phenomena in Patients With Various Intraocular Lens Implants
Sponsor:
Dr. Daniel H. Chang, MD
Organization:
Study Overview
Official Title:
Clinical Evaluation of Low Contrast Defocus Curves, Low Light Photic Phenomena, and Dysphotopsia Profiles in Pseudophakic Patients
Status:
RECRUITING
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: