Imaging Lens Deposits in Exfoliation Syndrome

Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT

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.

Study Overview

• Status: Terminated
• Conditions: Primary Open Angle Glaucoma; Cataracts; Exfoliation Syndrome
• Intervention / Treatment: Device: anterior segment OCT

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants will be recruited from Glaucoma and Comparehensive clinics at the duke Eye Center.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
exfoliation syndrome; patients with exfoliation syndrome	Device: anterior segment OCT
POAG; patients with primary open angle glaucoma (POAG)	Device: anterior segment OCT
cataracts; patients with cataracts	Device: anterior segment OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Amount of exfoliation deposits on the lens as measured by AS-OCT	20 min (length of imaging)

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): September 1, 2015

Study Registration Dates

• First Submitted: January 21, 2014
• First Submitted That Met QC Criteria: January 21, 2014
• First Posted (Estimate): January 23, 2014

Study Record Updates

• Last Update Posted (Estimate): October 21, 2015
• Last Update Submitted That Met QC Criteria: October 20, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease; Ocular Hypertension; Uveal Diseases; Lens Diseases; Glaucoma; Iris Diseases; Glaucoma, Open-Angle; Syndrome; Cataract; Exfoliation Syndrome
• Other Study ID Numbers: Pro00050919