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

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739397
• Other study ID #: EG-001
• Status: Completed
• Start date: November 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2016
• Source: Epico, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 89
• Est. completion date: June 2013
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• Glare Testing
Vision in Cataract patients were tested with and without the EpiGlare Tester

Locations

Country	Name	City	State
United States	The Eye Center of Columbus	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Epico, LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	User's assessment using a subjective questionnaire.	Users evaluated the device using a subjective questionnair	up to 16 months
Primary	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
Secondary	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