NCT00280345

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
23

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2006

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 19, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 23, 2006

Completed
9 days until next milestone

Study Start

First participant enrolled

February 1, 2006

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

December 15, 2023

Status Verified

December 1, 2023

Enrollment Period

1.6 years

First QC Date

January 19, 2006

Last Update Submit

December 8, 2023

Conditions

Pigmentary GlaucomaPrimary Open Angle GlaucomaCataract

Keywords

pigmentary glaucomaprimary open angle glaucomacataracttrabeculectomycataract surgery

Outcome Measures

Primary Outcomes (1)

  • Autoimmune Dysergulation in Pigmentary Glaucoma

    4 years

Interventions

TrabeculectomyPROCEDURE

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

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

Removal of the cataract from the eye

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • In the glaucoma patients, visual field and/or optic disc changes characteristic of glaucoma.
  • Ability to comprehend the information describing the clinical study.
  • Ability to provide signed and dated IRB-approved informed consent (ICF) for the study.

You may not qualify if:

  • 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.
  • Discernible congenital abnormality of the anterior chamber structures.
  • Neovascular, uveitic, traumatic, or infantile glaucoma.
  • Proliferative or severe non-proliferative diabetic retinopathy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dean A. McGee Eye Institute

Oklahoma City, Oklahoma, 73104, United States

Location

MeSH Terms

Conditions

Glaucoma, Open-AngleCataract

Interventions

TrabeculectomyCataract Extraction

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesLens Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, OperativeRefractive Surgical Procedures

Study Officials

  • Crystal McAfee, MA-HHSA

    Dean A. McGee Eye Institute

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 19, 2006

First Posted

January 23, 2006

Study Start

February 1, 2006

Primary Completion

September 1, 2007

Study Completion

May 1, 2009

Last Updated

December 15, 2023

Record last verified: 2023-12

Locations

US(1)