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Clinical Trials/NCT01931904
NCT01931904
Recruiting
Not Applicable

Observational Study of Ocular Blood Flow Pre- and Post- Glaucoma Surgery Using Functional and Structural Optical Coherence Tomography

Oregon Health and Science University1 site in 1 country46 target enrollmentFebruary 1, 2014
ConditionsGlaucoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
Oregon Health and Science University
Enrollment
46
Locations
1
Primary Endpoint
Effects of Intraocular Pressure (IOP) Reduction on Ocular Perfusion
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

The purpose of this study is to determine if lowering the pressure inside the eye improves blood flow to the eye.

Detailed Description

Using high-speed ocular coherence tomography (OCT) systems, we have developed new methods to image and measure optic nerve head (ONH) and retinal blood flow. Preliminary results have shown that visual field (VF) loss is more highly correlated with retinal blood flow as measured by OCT than any neural structure measured by OCT or other imaging modality. Accordingly, the goal of the proposed project is to improve the diagnostic and prognostic evaluation of glaucoma by further developing novel functional OCT measurements using ultrahigh-speed (70-100 kHz) OCT technology. Retinal blood flow, ONH circulation, optic disc rim volume, peripapillary nerve fiber layer volume, and macular ganglion cell complex volume are all pieces of the same glaucoma puzzle. This project will develop novel imaging methods that allow us to look at the whole picture using one tool - ultrahigh-speed OCT.

Registry
clinicaltrials.gov
Start Date
February 1, 2014
End Date
May 2026
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Huang

Aiyin Chen, MD, Associate Professor of Ophthalmology, Glaucoma Services Director

Oregon Health and Science University

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

Effects of Intraocular Pressure (IOP) Reduction on Ocular Perfusion

Time Frame: Subjects 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.

Study Sites (1)

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