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

NCT04739397 | Completed

• 1 other identifier: EG-001
• Study Type: observational
• Target: 89
• Locations: 1 country
• Sites: 1

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).

Conditions

Cataract

Keywords

Disability glare; contrast sensitivity; cataract; method evaluation; glare test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire

  up to 16 months

Other Outcomes (1)

• User's assessment using a subjective questionnaire.

  up to 16 months

Study Arms (2)

Cataract

Patients with bilateral cataracts with Lens grade 2+ or greater, cataract classification nuclear, cortical or posterior subcapsular

Device: Glare Testing

Non-Cataract

patients with bilateral clear lenses (no cataracts)

Device: Glare Testing

Interventions

Glare Testing DEVICE

Vision in Cataract patients were tested with and without the EpiGlare Tester

Also known as: EpiGlare Tester

Cataract; Non-Cataract

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Candidates were identified from the investigator's usual clinic population. Subjects presenting to the investigators clinic were examined according to the usual procedures. Subjects were classified as having either bilateral cataracts or clear lenses in both eyes

You may qualify if:

• clear lenses OU cataracts OU willing to comply with testing

You may not qualify if:

• 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

Sponsors & Collaborators

• Epico, LLC: lead

Study Sites (1)

The Eye Center of Columbus

Columbus, Ohio, 43215, United States

Location

Related Publications (1)

• Epitropoulos AT, Fram NR, Masket S, Price FW Jr, Snyder ME, Stulting RD. Evaluation of a New Controlled Point Source LED Glare Tester for Disability Glare Detection in Participants With and Without Cataracts. J Refract Surg. 2015 Mar;31(3):196-201. doi: 10.3928/1081597X-20150225-03.

  PMID: 25751837 BACKGROUND

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Officials

• Nicole R Fram, MD

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

• Samuel Masket, MD

  Advanced Vision Care

  PRINCIPAL INVESTIGATOR

• Fancis W Price, MD

  Price Vision Group

  PRINCIPAL INVESTIGATOR

• R. Doyle Stulting, MD, PhD

  Woolfson Eye Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2016
• First Posted: February 4, 2021
• Study Start: November 1, 2011
• Primary Completion: November 1, 2012
• Study Completion: June 1, 2013
• Last Updated: February 4, 2021

Record last verified: 2016-01

Locations

US (1)