Imaging Lens Deposits in Exfoliation Syndrome

Primary Open Angle Glaucoma Clinical Trial

Official title:

Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042703
• Other study ID #: Pro00050919
• Status: Terminated
• Phase: N/A
• First received: January 21, 2014
• Last updated: October 20, 2015
• Start date: February 2014
• Est. completion date: September 2015

Study information

• Verified date: October 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: September 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cataracts
• Exfoliation Syndrome
• Glaucoma, Open-Angle
• Primary Open Angle Glaucoma
• Syndrome

Intervention

Device:
• anterior segment OCT

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of exfoliation deposits on the lens as measured by AS-OCT		20 min (length of imaging)	No