Eye Pressure Lowering Surgery for Glaucoma

This observational study is looking at how lowering the pressure inside your eye (intraocular pressure or IOP) through surgery affects blood flow to your eye. Researchers want to see if improving blood flow helps with glaucoma. You might be able to join if you are between 18 and 85 years old, have open-angle or chronic angle-closure glaucoma, and are scheduled for either trabeculectomy or tube shunt surgery. The main goal is to measure the effects of eye pressure reduction on ocular perfusion (blood flow to the eye) over two years after surgery. The current status of this study is unclear.

Study design
This is an observational study with a planned enrollment of 46 participants. It is not specified if it is randomized or blinded.
What's involved
You will be evaluated before surgery and at 3, 6, 12, 18, and 24 months after surgery. These evaluations will involve imaging and measuring blood flow in your eye.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 months (2 years) after their surgery.

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NCT01931904

Eye Pressure Lowering Surgery

UNKNOWN
Not specifiedAges 18–85Observational
Oregon Health and Science University
~46 participants
Updated 2023-04-18 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Effects of Intraocular Pressure (IOP) Reduction on Ocular Perfusion
Measured over Subjects will be evaluated on enrollment (pre-operatively) and at post-operative visits ( 3, 6, 12, 18, and 24-months post-op).
Glaucoma
1 sites across 1 states
Oregon1
  • Aiyin Chen, MD · PRINCIPAL_INVESTIGATOR · Oregon Health and Science University

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Eligibility criteria

Inclusion

Subjects diagnosed with perimetric open angle glaucoma or chronic angle closure glaucoma.
Subjects scheduled to undergo trabeculectomy or tube shunt surgery

Exclusion

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
  • Effects of Intraocular Pressure (IOP) Reduction on Ocular PerfusionSubjects will be evaluated on enrollment (pre-operatively) and at post-operative visits ( 3, 6, 12, 18, and 24-months post-op).

    To determine if IOP reduction improves ocular perfusion. Change in IOP reduction will be measured in mmHg.