Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts
Study Details
Study Description
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
Inclusion Criteria:
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Are 18 years of age or older.
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Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination.
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Normal = lens opacity of clear or trace
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Cataract = lens opacity of 2+ or greater
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Have written informed consent as required by the site's IRB and received a copy.
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Are willing and able to comply with testing according to the Investigator.
Exclusion Criteria:
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Best corrected visual acuity is worse than 20/60 in either eye
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Have occular pathology including corneal or macular disease or advanced glaucoma
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Have cognitive dysfunction which limits the ability to cooperate with testing.
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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 Design
Arms and Interventions
| Arm | 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:
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| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
Other Outcome Measures
- User's assessment using a subjective questionnaire. [up to 16 months]
Users evaluated the device using a subjective questionnair
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Eye Center of Columbus | Columbus | Ohio | United States | 43215 |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
- EG-001