Eye Pressure Lowering Surgery
IOP
Observational Study of Ocular Blood Flow Pre- and Post- Glaucoma Surgery Using Functional and Structural Optical Coherence Tomography
2 other identifiers
observational
46
1 country
1
Brief Summary
The purpose of this study is to determine if lowering the pressure inside the eye improves blood flow to the eye.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Feb 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 27, 2013
CompletedFirst Posted
Study publicly available on registry
August 30, 2013
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2026
CompletedApril 18, 2023
April 1, 2023
12.3 years
August 27, 2013
April 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effects of Intraocular Pressure (IOP) Reduction on Ocular Perfusion
To determine if IOP reduction improves ocular perfusion. Change in IOP reduction will be measured in mmHg.
Subjects will be evaluated on enrollment (pre-operatively) and at post-operative visits ( 3, 6, 12, 18, and 24-months post-op).
Study Arms (1)
Trabeculectomy or Tube Shunt Patients
46 glaucoma patients undergoing trabeculectomy or tube shunt surgery to lower IOP
Eligibility Criteria
This study will measure blood flow changes in 46 glaucoma patients undergoing trabeculectomy or shunt surgery to lower IOP.
You may qualify if:
- Subjects diagnosed with perimetric open angle glaucoma or chronic angle closure glaucoma.
- Subjects scheduled to undergo trabeculectomy or tube shunt surgery
You may not qualify if:
- Best-corrected visual acuity less than 20/40
- Age \< 18 or \>85 years
- Refractive error of \> +3.00 D or \< -7.00 D
- Previous vision correction surgery such as Laser-Assisted in situ Keratomileusis (LASIK) or Photorefractive Keratectomy (PRK)
- Previous intraocular surgery except for uncomplicated cataract extraction with posterior chamber intraocular lens implantation
- Diabetic retinopathy
- History of heart failure, myocardial infarction, transient ischemic attack or stroke
- Other diseases that may cause VF loss or optic disc abnormalities
- Inability to clinically view or photograph the optic discs due to media opacity or poorly dilating pupil
- Inability to perform reliably on automated VF testing
- Life-threatening or debilitating illness making it unlikely patient will successfully complete the study.
- Refusal of informed consent or of commitment to the full length of the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Oregon Health and Science Universitylead
- National Eye Institute (NEI)collaborator
Study Sites (1)
OHSU
Portland, Oregon, 97239, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aiyin Chen, MD
Oregon Health and Science University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Aiyin Chen, MD, Associate Professor of Ophthalmology, Glaucoma Services Director
Study Record Dates
First Submitted
August 27, 2013
First Posted
August 30, 2013
Study Start
February 1, 2014
Primary Completion
May 1, 2026
Study Completion
May 1, 2026
Last Updated
April 18, 2023
Record last verified: 2023-04