Pigment Dispersion Syndrome With and Without Glaucoma

Glaucoma Clinical Trial

Official title:

Pigment Dispersion Syndrome With and Without Glaucoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00001152
• Other study ID #: 760189
• Secondary ID: 76-EI-0189
• Status: Completed
• Phase: N/A
• First received: November 3, 1999
• Last updated: March 3, 2008
• Start date: June 1976
• Est. completion date: June 2000

Study information

• Verified date: May 1998
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

To compare patients having PDS without and with OH or GL by documenting and following the clinical features and course of their disease and evaluating the patient's performance on a variety of diagnostic tests.

Description:

Pigment dispersion syndrome (PDS) is not an uncommon ocular condition and is frequently associated with myopia. There is loss of pigment from the posterior iris, seen clinically in most cases as iris transillumination with pigment deposited on the corneal endothelium, iris surface and on the angle structures overlying Schlemm's canal. In a subset of patients ocular hypertension or glaucoma may develop.

Ocular hypertension is defined as 3 separate measurements of the intraocular pressure greater than 22 mm/Hg in the absence of visual field loss. Glaucoma is defined as the presence of a characteristic field defect (Bjerrum scotoma, nasal step or arcuate scotomas) with intraocular pressures greater than 22 mm/Hg measured sometime during a diurnal curve testing.

The etiology of this condition is not known. Hypotheses include developmental abnormalities of the iris dilator muscle or mechanical rubbing of zonules against the iris, resulting in pigment dispersion in the anterior chamber and pressure elevation. PDS is then viewed as a variant of primary open-angle glaucoma or may be secondary to pigment deposited in the angle structures with secondary damage to the trabecular meshwork. A hereditary component does appear to play a role in the PDS syndrome and may also predispose to the development of glaucoma.

The purpose of this study is to evaluate and determine the risk factors that differentiate patients with PDS, PDS+OH, or PDS+GL by documenting the ophthalmic findings and following their clinical course. In order to do this, diagnostic tests including intraocular pressure and visual fields will be performed. This data may make it possible to determine the risk of patients having PDS of developing OH, GL or other possibly associated findings such as retinal detachment or cataract. In addition, patients with "pigmentary glaucoma (PG)" will be compared to those with the known characteristics of primary open-angle glaucoma (POAG) to determine whether PG is different than or a variant of POAG. When possible, family members will be examined to investigate the inheritance pattern of this syndrome and its relationship to POAG.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 175
• Est. completion date: June 2000
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Entrance into the study will depend upon clinical evidence of black pigment deposition on trabecular meshwork at the site of Schlemm's canal and at least one of the following: Kruckenberg spindle, pigment deposition on iris surface, or mid-stromal iris transillumination.

No patients with other ocular disease or disorders (uveitis, trauma, pseudoexfoliation, ICE syndrome, etc.)

Study Design

N/A

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Ocular Hypertension

Locations

Country	Name	City	State
United States	National Eye Institute (NEI)	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Andersen JS, Pralea AM, DelBono EA, Haines JL, Gorin MB, Schuman JS, Mattox CG, Wiggs JL. A gene responsible for the pigment dispersion syndrome maps to chromosome 7q35-q36. Arch Ophthalmol. 1997 Mar;115(3):384-8. — View Citation

Campbell DG. Pigmentary dispersion and glaucoma. A new theory. Arch Ophthalmol. 1979 Sep;97(9):1667-72. — View Citation

Kupfer C, Kuwabara T, Kaiser-Kupfer M. The histopathology of pigmentary dispersion syndrome with glaucoma. Am J Ophthalmol. 1975 Nov;80(5):857-62. — View Citation