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

NCT ID: NCT04739397

Last Updated: 2021-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-11-30

Study Completion Date

2013-06-30

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:

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.

Conditions

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Cataract

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cataract

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

Glare Testing

Intervention Type DEVICE

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

Non-Cataract

patients with bilateral clear lenses (no cataracts)

Glare Testing

Intervention Type DEVICE

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

Interventions

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Glare Testing

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

Intervention Type DEVICE

Other Intervention Names

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EpiGlare Tester

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Epico, LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicole R Fram, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Vision Care

Samuel Masket, MD

Role: PRINCIPAL_INVESTIGATOR

Advanced Vision Care

Fancis W Price, MD

Role: PRINCIPAL_INVESTIGATOR

Price Vision Group

R. Doyle Stulting, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Woolfson Eye Institute

Locations

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The Eye Center of Columbus

Columbus, Ohio, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 25751837 (View on PubMed)

Other Identifiers

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EG-001

Identifier Type: -

Identifier Source: org_study_id

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