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
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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COMPLETED
89 participants
OBSERVATIONAL
2011-11-30
2013-06-30
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
Vision in Cataract patients were tested with and without the EpiGlare Tester
Non-Cataract
patients with bilateral clear lenses (no cataracts)
Glare Testing
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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Epico, LLC
INDUSTRY
Responsible Party
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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
Countries
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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.
Other Identifiers
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EG-001
Identifier Type: -
Identifier Source: org_study_id
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