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Eye Pressure Lowering Surgery (IOP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2015 by David Huang, Oregon Health and Science University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01931904
First Posted: August 30, 2013
Last Update Posted: April 23, 2015
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. Read our disclaimer for details.
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
August 27, 2013
August 30, 2013
April 23, 2015
February 2014
June 2016   (Final data collection date for primary outcome measure)
Effects of Intraocular Pressure (IOP) Reduction on Ocular Perfusion [ Time Frame: 6 months ]
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 ClinicalTrials.gov Archive Site
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Eye Pressure Lowering Surgery
OBSERVATIONAL STUDY OF OCULAR BLOOD FLOW PRE- AND POST- TRABECULECTOMY 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
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample
This study will measure blood flow changes in 20 glaucoma patients undergoing trabeculectomy surgery to lower IOP. Another 20 patients undergoing cataract surgery will be selected as a control group.
Glaucoma
Not Provided
  • Trabeculectomy Patients
    20 glaucoma patients undergoing trabeculectomy surgery to lower IOP
  • Control Group
    20 patients undergoing cataract surgery will be selected as a control group
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
40
June 2016
June 2016   (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 surgery

Exclusion Criteria:

  • Best-corrected visual acuity less than 20/40
  • Age < 40 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
40 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01931904
IRB000009745
1R01EY023285 ( U.S. NIH Grant/Contract )
No
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David Huang, Oregon Health and Science University
Oregon Health and Science University
Not Provided
Principal Investigator: John Morrison, MD Oregon Health and Science University
Oregon Health and Science University
April 2015