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

Epico, LLC

Status: Completed

Conditions: Cataract

Treatments: Device: Glare Testing

Study type: Observational

Funder types: Industry

Identifiers

NCT04739397

EG-001

Details and patient eligibility

About

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).

Full 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.

Enrollment: 89 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

89 participants in 2 patient groups

Cataract

Description:

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

Treatment:

Device: Glare Testing

Non-Cataract

Description:

patients with bilateral clear lenses (no cataracts)

Treatment:

Device: Glare Testing