- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02042703
Imaging Lens Deposits in Exfoliation Syndrome
October 20, 2015 updated by: Duke University
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
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
North Carolina
-
Durham, North Carolina, United States, 27705
- Duke University Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
exfoliation syndrome
patients with exfoliation syndrome
|
|
POAG
patients with primary open angle glaucoma (POAG)
|
|
cataracts
patients with cataracts
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Amount of exfoliation deposits on the lens as measured by AS-OCT
Time Frame: 20 min (length of imaging)
|
20 min (length of imaging)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
Other Study ID Numbers
- Pro00050919
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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