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

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).

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Glare Testing

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 Type: Observational
• Enrollment (Actual): 89

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43215
      • The Eye Center of Columbus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
User's assessment using a subjective questionnaire.	Users evaluated the device using a subjective questionnair	up to 16 months

Collaborators and Investigators

• Sponsor: Epico, LLC
• Investigators: Principal Investigator: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: January 25, 2016
• First Submitted That Met QC Criteria: February 1, 2021
• First Posted (Actual): February 4, 2021

Study Record Updates

• Last Update Posted (Actual): February 4, 2021
• Last Update Submitted That Met QC Criteria: February 1, 2021
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: cataract; contrast sensitivity; Disability glare; method evaluation; glare test
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EG-001