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Imaging Lens Deposits in Exfoliation Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02042703
Recruitment Status : Terminated (Unanticipated slow enrollment)
First Posted : January 23, 2014
Last Update Posted : October 21, 2015
Information provided by (Responsible Party):
Duke University

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
Exfoliation Syndrome Primary Open Angle Glaucoma Cataracts Device: anterior segment OCT

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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 : February 2014
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

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

Primary Outcome Measures :
  1. Amount of exfoliation deposits on the lens as measured by AS-OCT [ Time Frame: 20 min (length of imaging) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants will be recruited from Glaucoma and Comparehensive clinics at the duke Eye Center.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02042703

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United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University

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Responsible Party: Duke University Identifier: NCT02042703     History of Changes
Other Study ID Numbers: Pro00050919
First Posted: January 23, 2014    Key Record Dates
Last Update Posted: October 21, 2015
Last Verified: October 2015
Additional relevant MeSH terms:
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Glaucoma, Open-Angle
Exfoliation Syndrome
Pathologic Processes
Ocular Hypertension
Eye Diseases
Lens Diseases
Iris Diseases
Uveal Diseases