Healthy Clinical Trial
Official title:
Etiology of Pigment Dispersion Syndrome (PDS)
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
1. Examination of the front of the eyes, including the cornea, iris and lens.
2. Vision testing and measurements of visual field and eye pressure.
3. 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
1. Refraction (dilation of the pupils with drops) and examination of the back of the eyes,
including the optic nerve.
2. 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.
Status | Completed |
Enrollment | 90 |
Est. completion date | August 2003 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | N/A and older |
Eligibility |
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. |
N/A
Country | Name | City | State |
---|---|---|---|
United States | National Eye Institute (NEI) | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Eye Institute (NEI) |
United States,
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. — View Citation
Ferris FL 3rd, Sperduto RD. Standardized illumination for visual acuity testing in clinical research. Am J Ophthalmol. 1982 Jul;94(1):97-8. — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06052553 -
A Study of TopSpin360 Training Device
|
N/A | |
Completed |
NCT05511077 -
Biomarkers of Oat Product Intake: The BiOAT Marker Study
|
N/A | |
Recruiting |
NCT04632485 -
Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
|
||
Completed |
NCT05931237 -
Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults
|
N/A | |
Terminated |
NCT04556032 -
Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women
|
N/A | |
Completed |
NCT04527718 -
Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers
|
Phase 1 | |
Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
Completed |
NCT04107441 -
AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects
|
Phase 1 | |
Completed |
NCT04065295 -
A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225
|
Phase 1 | |
Completed |
NCT01442831 -
Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects
|
Phase 1 | |
Terminated |
NCT05934942 -
A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood
|
Phase 1 | |
Recruiting |
NCT05525845 -
Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI
|
N/A | |
Completed |
NCT05515328 -
A Study in Healthy Men to Test How BI 685509 is Processed in the Body
|
Phase 1 | |
Completed |
NCT04967157 -
Cognitive Effects of Citicoline on Attention in Healthy Men and Women
|
N/A | |
Completed |
NCT05030857 -
Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects
|
Phase 1 | |
Recruiting |
NCT04714294 -
Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04494269 -
A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls
|
Phase 1 | |
Completed |
NCT04539756 -
Writing Activities and Emotions
|
N/A | |
Recruiting |
NCT04098510 -
Concentration of MitoQ in Human Skeletal Muscle
|
N/A | |
Completed |
NCT03308110 -
Bioavailability and Food Effect Study of Two Formulations of PF-06650833
|
Phase 1 |