GlaucomaNCT00001152
Pigment Dispersion Syndrome With and Without Glaucoma
An observational study of Glaucoma and Glaucoma, Open-Angle, run by National Eye Institute (NEI) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
- How many people
- 175 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 1976to Jun 2000
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.)
Trial locations and contacts
1 site in 1 country.
United States1 site
National Eye Institute (NEI)
Bethesda, Maryland, 20892
About this study
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.
Read the detailed 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.
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Aqueous Humor Dynamics, Glaucoma, Ocular Hypertension, Pigment Dispersion Syndrome, Primary Open Angle Glaucoma, Pseudo-Exfoliation of the Lens Capsule
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension, Glaucoma-Related Pigment Dispersion Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2002 (estimated)
- Study startJun 1976
- Study completionJun 2000
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 175 participants
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001152
- Sponsor's protocol ID
- 760189
- Other IDs
- 76-EI-0189
- Status last verified
- May 1998
- First submitted
- 3 Nov 1999
- Last updated
- 4 Mar 2008
- Results posted
- No
Publications
Kupfer C, Kuwabara T, Kaiser-Kupfer M. The histopathology of pigmentary dispersion syndrome with glaucoma. Am J Ophthalmol. 1975 Nov;80(5):857-62. doi: 10.1016/0002-9394(75)90283-4.
PubMed 1190279Campbell DG. Pigmentary dispersion and glaucoma. A new theory. Arch Ophthalmol. 1979 Sep;97(9):1667-72. doi: 10.1001/archopht.1979.01020020235011.
PubMed 475638Andersen 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. doi: 10.1001/archopht.1997.01100150386012.
PubMed 9076212
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pigment Dispersion Syndrome With and Without Glaucoma
- ClinicalTrials.gov ID
- NCT00001152
- Acronym / sponsor ID
- 760189
- Conditions
- Glaucoma, Glaucoma, Open-Angle, Ocular Hypertension
- Keywords
- Aqueous Humor Dynamics, Glaucoma, Ocular Hypertension, Pigment Dispersion Syndrome, Primary Open Angle Glaucoma, Pseudo-Exfoliation of the Lens Capsule
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 175 participants
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- Jun 1976
- Study completion
- Jun 2000
- First posted
- 10 Dec 2002 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2008.
- Background: PubMed 1190279Kupfer C, Kuwabara T, Kaiser-Kupfer M. The histopathology of pigmentary dispersion syndrome with glaucoma. Am J Ophthalmol. 1975 Nov;80(5):857-62. doi: 10.1016/0002-9394(75)90283-4.
- Background: PubMed 475638Campbell DG. Pigmentary dispersion and glaucoma. A new theory. Arch Ophthalmol. 1979 Sep;97(9):1667-72. doi: 10.1001/archopht.1979.01020020235011.
- Background: PubMed 9076212Andersen 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. doi: 10.1001/archopht.1997.01100150386012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma and Glaucoma, Open-Angle, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00001152, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2008.