Imaging Lens Deposits in Exfoliation Syndrome

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02042703
• Collaborator: (none)
• Enrollment: 4
• Location: 1
• Duration (Months): 19
• Patients Per Site Per Month: 0.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Exfoliation Syndrome; Primary Open Angle Glaucoma; Cataracts	Device: anterior segment OCT

Study Design

• Study Type: Observational
• Actual Enrollment: 4 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Imaging Lens Changes in Exfoliation Syndrome Using Anterior Segment OCT
• Study Start Date: Feb 1, 2014
• Actual Primary Completion Date: Sep 1, 2015
• Actual Study Completion Date: Sep 1, 2015

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Amount of exfoliation deposits on the lens as measured by AS-OCT [20 min (length of imaging)]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University Medical Center	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT02042703
• Other Study ID Numbers: Pro00050919
• First Posted: Jan 23, 2014
• Last Update Posted: Oct 21, 2015
• Last Verified: Oct 1, 2015

• Additional relevant MeSH terms: Cataract; Glaucoma, Open-Angle; Exfoliation Syndrome; Syndrome

Study Results

No Results Posted as of Oct 21, 2015