Cataract
Conditions
Keywords
Disability glare, contrast sensitivity, cataract, method evaluation, glare test
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).
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.
Interventions
DEVICEGlare Testing
Vision in Cataract patients were tested with and without the EpiGlare Tester
Sponsors
Epico, LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| User's assessment using a subjective questionnaire. | up to 16 months | Users evaluated the device using a subjective questionnair |
Countries
United States
Outcome results
None listed