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OpenTrials
Completed

NCT Number: NCT04739397

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

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).

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Key information

Conditions

Cataract Eye Diseases Lens Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

The Eye Center of Columbus

Columbus, Ohio, 43215, United States

About this study

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.
  • Normal = lens opacity of clear or trace
  • Cataract = lens opacity of 2+ or greater
  • 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

  • Best corrected visual acuity is worse than 20/60 in either eye
  • Have occular pathology including corneal or macular disease or advanced glaucoma
  • Have cognitive dysfunction which limits the ability to cooperate with testing.
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Glare Testing

Device

Vision in Cataract patients were tested with and without the EpiGlare Tester

Other names: EpiGlare Tester

Primary outcomes

  1. Change in best spectacle corrected visual acuity (BSCVA) measurements before and after glare testing using the EpiGlare Tester as the glare source.

    Time frame: 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 outcomes

  1. Evaluation of functional visual ability using driving and glare subscales from the Refractive Status Vision Profile (RSVP) questionnaire

    Time frame: 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 outcomes

  1. User's assessment using a subjective questionnaire.

    Time frame: up to 16 months

    Users evaluated the device using a subjective questionnair

Sponsors and collaborators

Lead sponsor

Epico, LLC

Industry

Registry information

Important dates

Study start
2011
Primary completion
2012
Study completion
2013
First posted
Feb 4, 2021
Registry last updated
Feb 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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