Eye Pressure Lowering Surgery (IOP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01931904
Recruitment Status : Recruiting
First Posted : August 30, 2013
Last Update Posted : April 12, 2018
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

August 27, 2013
August 30, 2013
April 12, 2018
February 2014
December 2022   (Final data collection date for primary outcome measure)
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.
Effects of IOP Reduction on Ocular Perfusion [ Time Frame: 6 months ]
To determine if IOP reduction improves ocular perfusion.
Complete list of historical versions of study NCT01931904 on Archive Site
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Eye Pressure Lowering Surgery
Observational Study of Ocular Blood Flow Pre- and Post- Glaucoma Surgery Using Functional and Structural Optical Coherence Tomography
The purpose of this study is to determine if lowering the pressure inside the eye improves blood flow to the eye.

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.

Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
This study will measure blood flow changes in 46 glaucoma patients undergoing trabeculectomy or shunt surgery to lower IOP.
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Trabeculectomy or Tube Shunt Patients
46 glaucoma patients undergoing trabeculectomy or tube shunt surgery to lower IOP
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
December 2022
December 2022   (Final data collection date for primary outcome measure)

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 >80 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
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Older Adult)
Contact: Rachel McClain, COA 503-494-9628
Contact: Denny Romfh, OD 503-494-4351
United States
1R01EY023285 ( U.S. NIH Grant/Contract )
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David Huang, Oregon Health and Science University
Oregon Health and Science University
National Eye Institute (NEI)
Principal Investigator: John Morrison, MD Oregon Health and Science University
Oregon Health and Science University
April 2018