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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).
Inclusion Criteria:
Are 18 years of age or older.
Have been evaluated by an opthalmologist and have a lens determination of either Normal or Cataract in each eye based on slit lamp examination.
Have written informed consent as required by the site's IRB and received a copy.
Are willing and able to comply with testing according to the Investigator.
Exclusion Criteria:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cataract | Patients with bilateral cataracts with Lens grade 2+ or greater, cataract classification nuclear, cortical or posterior subcapsular |
| |
| Non-Cataract | patients with bilateral clear lenses (no cataracts) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Glare Testing | Device | Vision in Cataract patients were tested with and without the EpiGlare Tester |
|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| User's assessment using a subjective questionnaire. | Users evaluated the device using a subjective questionnair | up to 16 months |
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
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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
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Eye Center of Columbus | Columbus | Ohio | 43215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25751837 | Background | 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. |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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