Clinical trial NCT04739397: Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts
Official title: Evaluation of the EpiGlare Tester for the Measurement of Glare-Induced Changes in BSCVA in Subjects With and Without Cataracts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataract
Keywords: Disability glare
contrast sensitivity
cataract
method evaluation
glare test
Lead sponsor: Epico, LLC
Sponsor class: INDUSTRY
First posted: 2021-02-04
Enrollment: 89
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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

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.

Eligibility 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

Primary outcomes:
measure: Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.
timeFrame: up to 16 months
Secondary outcomes:
measure: Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire
timeFrame: up to 16 months
Other outcomes:
measure: User's assessment using a subjective questionnaire.
timeFrame: up to 16 months
Locations:
city: Columbus
country: United States
facility: The Eye Center of Columbus
state: Ohio
Study officials:
affiliation: Advanced Vision Care
name: Nicole R Fram, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Vision Care
name: Samuel Masket, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Price Vision Group
name: Fancis W Price, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Woolfson Eye Institute
name: R. Doyle Stulting, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.