Imaging Lens Deposits in Exfoliation Syndrome

NCT ID: NCT02042703

Last Updated: 2015-10-21

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 4 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-09-30

Brief Summary

The purpose of this study is to use a special eye imaging technique, anterior segment optical coherence tomography (AS-OCT), to image the lens (the curved, transparent part of the eye that helps you to see clearly by directing images of light onto the back of your eye) and note any changes in exfoliation syndrome. Exfoliation syndrome is a common condition that has many ways of showing up in the eye, including the formation of deposits in the eye, shakiness of the lens that can complicate cataract surgery, and a higher chance of developing a type of glaucoma called exfoliation glaucoma. In this study we plan to collect images and measure exfoliation deposits on the lens with AS-OCT, which can take high resolution pictures of the eye without requiring contact with the eye. We will compare lens images of subjects with exfoliation syndrome to those of subjects with primary open angle glaucoma and cataracts. This type of imaging could be used in patients with known diagnosis of exfoliation syndrome to track disease progression and see how they respond to possible treatments. We also hope that with this imaging technology we can detect early changes in currently unaffected eyes, which could be useful for predicting which patients may develop the disease.

Conditions

Exfoliation Syndrome; Primary Open Angle Glaucoma; Cataracts

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

exfoliation syndrome

patients with exfoliation syndrome

anterior segment OCT

Intervention Type: DEVICE

POAG

patients with primary open angle glaucoma (POAG)

anterior segment OCT

Intervention Type: DEVICE

cataracts

patients with cataracts

anterior segment OCT

Intervention Type: DEVICE

Interventions

anterior segment OCT

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts

Exclusion Criteria

• Unable to provide or sign consent
• Pseudophakia
• Other prior intraocular surgery
• Other eye diseases other than refractive error

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00050919

Identifier Type: -

Identifier Source: org_study_id