Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts

Study Overview
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Brief Summary
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The EpiGlare Tester will identify visual disability resulting from the glare experienced by subjects with cataracts in the glare-induced change in best spectacle corrected visual acuity (BSCVA).

Detailed Description
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Inclusion Criteria: Are 18 years of age or older. Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination. Normal = lens opacity of clear or trace Cataract = lens opacity of 2+ or greater Have written informed consent as required by the site's IRB and received a copy. Are willing and able to comply with testing according to the Investigator. Exclusion Criteria: Best corrected visual acuity is worse than 20/60 in either eye Have occular pathology including corneal or macular disease or advanced glaucoma Have cognitive dysfunction which limits the ability to cooperate with testing. Have presence or history of any other condition or finding or concomitant medication that, in the investigator's opinion, makes the subject unsuitable as a candidate for EpiGlare or study participation or may confound the outcome of the study.

Official Title
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Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts

Conditions
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Cataract

Intervention / Treatment
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* Device: Glare Testing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: clear lenses OU cataracts OU willing to comply with testing Exclusion Criteria: BCVA < 20/63 either eye ocular pathology (ie corneal, macular disease, advanced glaucoma) cognitive dysfunction other conditions that in the investigators opinion made the subject unsuitable candidate

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cataract<br>Patients with bilateral cataracts with Lens grade 2+ or greater, cataract classification nuclear, cortical or posterior subcapsular | Device: Glare Testing<br>* Vision in Cataract patients were tested with and without the EpiGlare Tester<br>* Other names: EpiGlare Tester;|
| Non-Cataract<br>patients with bilateral clear lenses (no cataracts) | Device: Glare Testing<br>* Vision in Cataract patients were tested with and without the EpiGlare Tester<br>* Other names: EpiGlare Tester;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source. | Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source in patients with and without cataracts. | up to 16 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire | Correlation of the EpiGlare Tester's glare-induced changes in BSCVA with functional glare disability, as measured by the glare subcategory from the RSVP questionnaire | up to 16 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Disability glare, contrast sensitivity, cataract, method evaluation, glare test