Cataract Clinical Trial
Official title:
Effect of Blue Light Filtration on Visual Performance
Verified date | January 2015 |
Source | Alcon Research |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 158 |
Est. completion date | January 2014 |
Est. primary completion date | January 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 21 Years and older |
Eligibility |
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. |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Alcon Research |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | No |
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