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

Completed

• Conditions: Cataract
• Interventions: Device: Glare Testing

• Registration Number: NCT04739397
• Lead Sponsor: Epico, LLC

Brief Summary

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

Inclusion Criteria:

1. Are 18 years of age or older.

2. Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination.

1. Normal = lens opacity of clear or trace

2. Cataract = lens opacity of 2+ or greater

3. Have written informed consent as required by the site's IRB and received a copy.

4. Are willing and able to comply with testing according to the Investigator.

Exclusion Criteria:

1. Best corrected visual acuity is worse than 20/60 in either eye

2. Have occular pathology including corneal or macular disease or advanced glaucoma

3. Have cognitive dysfunction which limits the ability to cooperate with testing.

4. 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.

Study Timeline

• Study Start: 2011-11
• Primary Completion: 2012-11
• Study Completion: 2013-06
• Status Verified: 2016-01
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2021-02-01
• Last Update Submitted: 2021-02-01
• Study First Posted: 2021-02-04
• Last Update Posted: 2021-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 89

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Non-Cataract	Glare Testing	patients with bilateral clear lenses (no cataracts)
Cataract	Glare Testing	Patients with bilateral cataracts with Lens grade 2+ or greater, cataract classification nuclear, cortical or posterior subcapsular

Primary Outcome Measures

Name	Time	Method
Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.	up to 16 months	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.

Secondary Outcome Measures

Name	Time	Method
Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire	up to 16 months	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

Trial Locations

Locations (1)

The Eye Center of Columbus; 🇺🇸 Columbus, Ohio, United States