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Cause of Pigment Dispersion Syndrome

Primary Purpose

Glaucoma, Healthy, Pigment Dispersion Syndrome

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Eye Institute (NEI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Glaucoma focused on measuring Pigment Dispersion, Ocular Hypertension, Glaucoma, Pupil Reaction, Natural History, Pigment Dispersion Syndrome, Gene Mutation

Eligibility Criteria

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INCLUSION CRITERIA: All patients entering the study must have black pigment deposition on the trabecular meshwork at the site of Schlemm's canal equal to or greater than 2-plus on the goniophotographic scale of 1 to 5 plus. Although this condition is rare amongst African-Americans, every effort will be made to recruit such individuals. EXCLUSION CRITERIA: Patients with exfoliation syndrome, uveitis, trauma, pigment dispersion with posterior chamber intra-ocular lens, pigmented tumors, primary open-angle glaucoma, other conditions with associated pigment dispersion such as acute angle-closure glaucoma, ocular hemorrhage, Horner's syndrome. In addition, normal volunteers will be recruited as controls. They will be free of any eye disease and be matched for age, sex and degree of myopia.

Sites / Locations

  • National Eye Institute (NEI)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 17, 2000
Last Updated
March 3, 2008
Sponsor
National Eye Institute (NEI)
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1. Study Identification

Unique Protocol Identification Number
NCT00005919
Brief Title
Cause of Pigment Dispersion Syndrome
Official Title
Etiology of Pigment Dispersion Syndrome (PDS)
Study Type
Observational

2. Study Status

Record Verification Date
August 2003
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2003 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Eye Institute (NEI)

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to learn how pigment is released from the iris (the colored part of the eye) in patients with pigment dispersion syndrome. It will do this by examining the response of the pupil (the central opening of the iris) to a flash of light to determine what is happening in the iris to cause release of the pigment. In pigment dispersion syndrome, pigment released from the iris is deposited in other parts of the eye, including the trabecular meshwork-a filter-like tissue in the front of the eye. Aqueous fluid (fluid continuously produced by the eye) normally flows out of the eye through the trabecular meshwork. In some patients, the pigment deposits may block tiny holes in the meshwork, preventing the fluid from flowing out. This can cause an increase in eye pressure that may lead to glaucoma and some loss of vision. Understanding how pigment is released from the iris may help predict the course of pigment dispersion syndrome and identify which patients will likely develop increased eye pressure. Patients with pigment dispersion syndrome and normal volunteers may be eligible for this study. All participants will have the following procedures, which will be completed in two clinic visits: First visit Examination of the front of the eyes, including the cornea, iris and lens. Vision testing and measurements of visual field and eye pressure. Examination of the trabecular meshwork. For this test, a contact lens is placed on the eye after the eye has been numbed with anesthetic drops. Second visit Refraction (dilation of the pupils with drops) and examination of the back of the eyes, including the optic nerve. Reaction of the pupils to low-level infrared light (pupillography). During this 15-minute test, the patient or volunteer wears a lightweight headband with two small cameras mounted on it. The cameras-one which views the eye and the other the subject's field of view-record pupil dilation and position. The test results in patients with pigment dispersion syndrome will be compared with those in normal volunteers. Patients will be followed every 6 months (or more often, if medically indicated) during the 3-year study to determine changes in eye pressure or visual field. Volunteers will be asked to return about once a year for 3 years for repeat pupillography.
Detailed Description
The purpose of this study is to conduct a comprehensive ophthalmologic evaluation and comparison of two types of patients and to compare them to normal controls. The two types of patients are those with pigment dispersion (PDS) with normal intraocular pressure (IOP) and those with PDS and elevated IOP. The hypothesis to be tested is that a developmental abnormality of the iris pigment epithelium (IPE) and the dilator muscle is the fundamental defect responsible for the pigment dispersion. This defect may involve other structures of the eye such as the ciliary and retinal pigment epithelium. The results of pupillography in PDS with or without elevated IOP and asymmetric PDS (one eye versus fellow eye) will be the outcome parameters.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Healthy, Pigment Dispersion Syndrome
Keywords
Pigment Dispersion, Ocular Hypertension, Glaucoma, Pupil Reaction, Natural History, Pigment Dispersion Syndrome, Gene Mutation

7. Study Design

Enrollment
90 (false)

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: All patients entering the study must have black pigment deposition on the trabecular meshwork at the site of Schlemm's canal equal to or greater than 2-plus on the goniophotographic scale of 1 to 5 plus. Although this condition is rare amongst African-Americans, every effort will be made to recruit such individuals. EXCLUSION CRITERIA: Patients with exfoliation syndrome, uveitis, trauma, pigment dispersion with posterior chamber intra-ocular lens, pigmented tumors, primary open-angle glaucoma, other conditions with associated pigment dispersion such as acute angle-closure glaucoma, ocular hemorrhage, Horner's syndrome. In addition, normal volunteers will be recruited as controls. They will be free of any eye disease and be matched for age, sex and degree of myopia.
Facility Information:
Facility Name
National Eye Institute (NEI)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
7091290
Citation
Ferris FL 3rd, Sperduto RD. Standardized illumination for visual acuity testing in clinical research. Am J Ophthalmol. 1982 Jul;94(1):97-8. doi: 10.1016/0002-9394(82)90198-2. No abstract available.
Results Reference
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PubMed Identifier
7091289
Citation
Ferris FL 3rd, Kassoff A, Bresnick GH, Bailey I. New visual acuity charts for clinical research. Am J Ophthalmol. 1982 Jul;94(1):91-6.
Results Reference
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Cause of Pigment Dispersion Syndrome

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