Imaging Lens Deposits in Exfoliation Syndrome

NCT02042703 | Terminated DMC

• 1 other identifier: Pro00050919
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Exfoliation Syndrome; Primary Open Angle Glaucoma; Cataracts

Outcome Measures

Primary Outcomes (1)

• Amount of exfoliation deposits on the lens as measured by AS-OCT

  20 min (length of imaging)

Study Arms (3)

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

Interventions

anterior segment OCT DEVICE

POAG; cataracts; exfoliation syndrome

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Diagnosis of exfoliation syndrome, primary open angle glaucoma (POAG), or cataracts

You may not qualify if:

• Unable to provide or sign consent
• Pseudophakia
• Other prior intraocular surgery
• Other eye diseases other than refractive error

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Exfoliation Syndrome; Glaucoma, Open-Angle; Cataract

Condition Hierarchy (Ancestors)

Iris Diseases; Uveal Diseases; Eye Diseases; Glaucoma; Ocular Hypertension; Lens Diseases

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 21, 2014
• First Posted: January 23, 2014
• Study Start: February 1, 2014
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: October 21, 2015

Record last verified: 2015-10

Locations

US (1)