Pigmentary GlaucomaNCT00280345
Autoimmune Dysregulation in Pigmentary Glaucoma
A study testing Trabeculectomy, Trabeculectomy and cataract surgery and Cataract surgery in people with Pigmentary Glaucoma and Primary Open Angle Glaucoma, run by University of Oklahoma at 1 site in United States.
Trial summary
Based on these recent observations and findings in this new animal model of pigmentary glaucoma in the DBA/2J mouse, we propose that immune system abnormalities in the anterior chamber may play a possible role in the development of pigmentary glaucoma and possibly primary open-angle glaucoma (POAG) in humans. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pigmentary Glaucoma, Primary Open Angle Glaucoma, Cataract
- What is being tested?
- Trabeculectomy, Trabeculectomy and cataract surgery and Cataract surgery
- Type of treatment
- Surgery or procedure
- How many people
- 23 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2006to May 2009
- Phase
- Interventional
- 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 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Any clinically significant uncontrolled medical condition(s) that might, in the investigators' opinion, interfere with the assessment.
- Use of corticosteroids within 3 months prior to surgery.
- Use of systemic anti-metabolites within 6 weeks prior to surgery.
- Use of any investigational drug within 4 weeks prior to surgery.
- Specific to the study eye exclusions:
- History of non-iatrogenic uveitis or active uveitis.
Show all 9Show fewer
- Discernible congenital abnormality of the anterior chamber structures.
- Neovascular, uveitic, traumatic, or infantile glaucoma.
- Proliferative or severe non-proliferative diabetic retinopathy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Dean A. McGee Eye Institute
Oklahoma City, Oklahoma, 73104
About this study
Based on these recent observations and findings in this new animal model of pigmentary glaucoma in the DBA/2J mouse, we propose that immune system abnormalities in the anterior chamber may play a possible role in the development of pigmentary glaucoma and possibly primary open-angle glaucoma (POAG) in humans.
Read the detailed description
The aim is to establish, through tissue and aqueous analysis of patients with pigmentary glaucoma, POAG and normal controls, that markers for anterior chamber autoimmune dysfunction occur in significantly different amounts in patients with these conditions when compared to normal controls. We also will attempt to establish, through proven methodologies of tissue gene expression, that the source of these differences in markers, notably PEDF and IL-18, is from the uveal tissues of the anterior chamber, most importantly the iris and possibly the trabecular meshwork as well.
The actual etiology at the cellular level of elevated intraocular pressure and the development of pigmentary glaucoma is not well understood in humans. If anterior chamber immune dysfunction were shown to be an important factor in the development of this disease in humans, which apparently is demonstrated by the DBA/2J mouse, it would lead to an important area of further investigation and possible novel approaches in treating or preventing this disease in humans.
We hypothesize that in patients with pigmentary glaucoma, the amount of PEDF in the aqueous is significantly reduced while IL-18 is significantly elevated when compared to the aqueous of normal controls. In patients with POAG, we hypothesize similar results for PEDF, although significantly less reduction of PEDF when compared to the pigmentary glaucoma patients may be an interesting finding as well. With regard to IL-18, it is possible that amounts would be significantly elevated in the pigmentary glaucoma patients when compared to both normal controls and POAG patients. In view of the results from the DBA/2J mouse model, we hope to determine whether expression of PEDF could be down regulated in the iris and/or trabecular meshwork of pigmentary glaucoma patients when compared to POAG patients and whether IL-18 expression in these tissues could be up regulated in pigmentary glaucoma patients when compared to POAG patients.
Such findings would strongly suggest that anterior chamber immune abnormalities play a role in the etiology of pigmentary glaucoma in humans. It already has been suggested that decreased amounts and expression of PEDF are found in patients with glaucoma and other neurodegenerative diseases of the eye. However, the source of the decreased expression has not been identified. If IL-18 production is elevated in pigmentary glaucoma and is up regulated in the anterior chamber structures of the eye in human patients with the disease, this also would be highly suggestive that localized anterior chamber immune dysfunction plays a role in the development of this disease.
Depending on our findings, additional investigations of autoimmune dysregulation in pigmentary glaucoma (and perhaps other secondary glaucomas) may help determine the predictive value of such markers in identifying whether or not patients with pigment dispersion syndrome develop glaucomatous damage.
- Conditions
- Pigmentary Glaucoma, Primary Open Angle Glaucoma, Cataract
- Being tested
- Trabeculectomy, Trabeculectomy and cataract surgery, Cataract surgery
- Keywords
- pigmentary glaucoma, primary open angle glaucoma, cataract, trabeculectomy, cataract surgery
- Medical subject headings
- Glaucoma, Open-Angle, Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrabeculectomyProcedure or surgery
A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork
Trabeculectomy and cataract surgeryProcedure or surgery
A surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork and the removal of the cataract
Cataract surgeryProcedure or surgery
Removal of the cataract from the eye
What is being measured
The primary outcome is the main question the study is designed to answer.
Autoimmune Dysergulation in Pigmentary Glaucoma
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2006 (estimated)
- Study startFeb 2006
- Primary completionSep 2007
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pigmentary GlaucomaStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Crystal McAfee, MA-HHSA, Study director, Dean A. McGee Eye Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00280345
- Sponsor's protocol ID
- Pigmentary Glaucoma
- Status last verified
- Dec 2023
- First submitted
- 19 Jan 2006
- Last updated
- 15 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autoimmune Dysregulation in Pigmentary Glaucoma
- ClinicalTrials.gov ID
- NCT00280345
- Acronym / sponsor ID
- Pigmentary Glaucoma
- Conditions
- Pigmentary Glaucoma, Primary Open Angle Glaucoma, Cataract
- Keywords
- pigmentary glaucoma, primary open angle glaucoma, cataract, trabeculectomy, cataract surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- Feb 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 23 Jan 2006 (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.
Based on these recent observations and findings in this new animal model of pigmentary glaucoma in the DBA/2J mouse, we propose that immune system abnormalities in the anterior chamber may play a possible role in the development of pigmentary glaucoma and possibly primary open-angle glaucoma (POAG) in humans.
Detailed description
The aim is to establish, through tissue and aqueous analysis of patients with pigmentary glaucoma, POAG and normal controls, that markers for anterior chamber autoimmune dysfunction occur in significantly different amounts in patients with these conditions when compared to normal controls. We also will attempt to establish, through proven methodologies of tissue gene expression, that the source of these differences in markers, notably PEDF and IL-18, is from the uveal tissues of the anterior chamber, most importantly the iris and possibly the trabecular meshwork as well.
The actual etiology at the cellular level of elevated intraocular pressure and the development of pigmentary glaucoma is not well understood in humans. If anterior chamber immune dysfunction were shown to be an important factor in the development of this disease in humans, which apparently is demonstrated by the DBA/2J mouse, it would lead to an important area of further investigation and possible novel approaches in treating or preventing this disease in humans.
We hypothesize that in patients with pigmentary glaucoma, the amount of PEDF in the aqueous is significantly reduced while IL-18 is significantly elevated when compared to the aqueous of normal controls. In patients with POAG, we hypothesize similar results for PEDF, although significantly less reduction of PEDF when compared to the pigmentary glaucoma patients may be an interesting finding as well. With regard to IL-18, it is possible that amounts would be significantly elevated in the pigmentary glaucoma patients when compared to both normal controls and POAG patients. In view of the results from the DBA/2J mouse model, we hope to determine whether expression of PEDF could be down regulated in the iris and/or trabecular meshwork of pigmentary glaucoma patients when compared to POAG patients and whether IL-18 expression in these tissues could be up regulated in pigmentary glaucoma patients when compared to POAG patients.
Such findings would strongly suggest that anterior chamber immune abnormalities play a role in the etiology of pigmentary glaucoma in humans. It already has been suggested that decreased amounts and expression of PEDF are found in patients with glaucoma and other neurodegenerative diseases of the eye. However, the source of the decreased expression has not been identified. If IL-18 production is elevated in pigmentary glaucoma and is up regulated in the anterior chamber structures of the eye in human patients with the disease, this also would be highly suggestive that localized anterior chamber immune dysfunction plays a role in the development of this disease.
Depending on our findings, additional investigations of autoimmune dysregulation in pigmentary glaucoma (and perhaps other secondary glaucomas) may help determine the predictive value of such markers in identifying whether or not patients with pigment dispersion syndrome develop glaucomatous damage.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (9 listed)
- Any clinically significant uncontrolled medical condition(s) that might, in the investigators' opinion, interfere with the assessment.
- Use of corticosteroids within 3 months prior to surgery.
- Use of systemic anti-metabolites within 6 weeks prior to surgery.
- Use of any investigational drug within 4 weeks prior to surgery.
- History of non-iatrogenic uveitis or active uveitis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrabeculectomyA surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork | Procedure or surgery | – |
| Trabeculectomy and cataract surgeryA surgical procedure used in the treatment of glaucoma to relieve intraocular pressure by removing part of the eye's trabecular meshwork and the removal of the cataract | Procedure or surgery | – |
| Cataract surgeryRemoval of the cataract from the eye | Procedure or surgery | – |
Primary outcome
Autoimmune Dysergulation in Pigmentary Glaucoma
Time frame: 4 years
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 15 Dec 2023.
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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.
Crystal McAfee, MA-HHSA study director
Dean A. McGee Eye Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trabeculectomy, Trabeculectomy and cataract surgery and Cataract surgery in people with Pigmentary Glaucoma and Primary Open Angle Glaucoma, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2023. 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.
What does the primary outcome measure?
Autoimmune Dysergulation in Pigmentary Glaucoma (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Dec 2023.