Eye Pressure Lowering Surgery (IOP)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2014 by Oregon Health and Science University
Sponsor:
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University
ClinicalTrials.gov Identifier:
NCT01931904
First received: August 27, 2013
Last updated: October 14, 2014
Last verified: October 2014

August 27, 2013
October 14, 2014
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 ] [ Designated as safety issue: No ]
To determine if IOP reduction improves ocular perfusion.
Effects of IOP Reduction on Ocular Perfusion [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
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
Both
40 Years to 80 Years
No
Contact: Janice Ladwig 503-494-8024 ladwig@ohsu.edu
Contact: Denny Romfh 503-494-4351 romfhd@ohsu.edu
United States
 
NCT01931904
IRB000009745, 1R01EY023285
No
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
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP