Effect of Blue Light Filtration on Visual Performance

Study Overview
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Brief Summary
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The purpose of this study is to evaluate photostress recovery with blue light filter clip-on glasses among pseudophakes [ie, subjects in which the natural lens of the eye has been replaced with an artificial lens (intraocular lens) during cataract surgery]. This study will enroll subjects previously implanted with no blue light filter intraocular lenses (IOLs) for at least 3 months.

Official Title
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Effect of Blue Light Filtration on Visual Performance

Conditions
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Cataract

Intervention / Treatment
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* Device: Clear clip-on glasses
* Device: Blue light filter clip-on glasses


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Cataract surgery in both eyes with no blue light filtering intraocular lenses for at least 3 months; Good ocular health; 20/40 or better vision with best correction in both eyes; Willing to provide voluntary consent and sign informed consent form; Able to competently perform testing; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Ocular pathology, degeneration, or media opacity (cloudiness) that could impact study measurements; Other protocol-defined exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Clear, then Blue Light Filter<br>Clear clip-on glasses first, followed by blue light filter clip-on glasses, as worn over habitual correction | Device: Clear clip-on glasses<br>* Clip-on glasses with no light filtering properties<br>Device: Blue light filter clip-on glasses<br>* Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs<br>|
| Other: Blue Light Filter, then Clear<br>Blue light filter clip-on glasses first, followed by clear clip-on glasses, as worn over habitual correction | Device: Clear clip-on glasses<br>* Clip-on glasses with no light filtering properties<br>Device: Blue light filter clip-on glasses<br>* Clip-on glasses with blue light filtering properties equivalent to AcrySof IOLs<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Photostress Recovery Time | Photostress Recovery Time is the time necessary to recover function (e.g., contrast discrimination) following exposure to a bright glare source. The subject fixated on an image (black and white grating) and underwent photostress (glare) for 5 seconds. Only 1 eye (study eye) was assessed. | Day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cataract, intraocular lens, IOL, blue light filter