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Eye Pressure Lowering Surgery (IOP)

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ClinicalTrials.gov Identifier: NCT01931904
Recruitment Status : Recruiting
First Posted : August 30, 2013
Last Update Posted : April 12, 2018
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
David Huang, Oregon Health and Science University

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

Condition or disease
Glaucoma

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.


Study Type : Observational
Estimated Enrollment : 46 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study of Ocular Blood Flow Pre- and Post- Glaucoma Surgery Using Functional and Structural Optical Coherence Tomography
Study Start Date : February 2014
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Group/Cohort
Trabeculectomy or Tube Shunt Patients
46 glaucoma patients undergoing trabeculectomy or tube shunt surgery to lower IOP



Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
This study will measure blood flow changes in 46 glaucoma patients undergoing trabeculectomy or shunt surgery to lower IOP.
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 >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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01931904


Contacts
Contact: Rachel McClain, COA 503-494-9628 mcclainr@ohsu.edu
Contact: Denny Romfh, OD 503-494-4351 romfhd@ohsu.edu

Locations
United States, Oregon
OHSU Recruiting
Portland, Oregon, United States, 97239
Contact: Rachel McClain, COA    503-494-9628    mcclainr@ohsu.edu   
Contact: Denny Romfh, OD    503-494-4351    romfhd@ohsu.edu   
Sub-Investigator: Beth Edmunds, MD, PhD         
Sub-Investigator: Mansi Parikh, MD         
Sub-Investigator: Hana Takusagawa, MD         
Sub-Investigator: Lorinna Lombardi, MD         
Sub-Investigator: David Huang, MD, PhD         
Sub-Investigator: Shandiz Tehrani, MD         
Sponsors and Collaborators
Oregon Health and Science University
National Eye Institute (NEI)
Investigators
Principal Investigator: John Morrison, MD Oregon Health and Science University

Additional Information:
Responsible Party: David Huang, John Morrison, MD, Professor of Ophthalmology, Glaucoma Services Director, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01931904     History of Changes
Other Study ID Numbers: IRB000009745
1R01EY023285 ( U.S. NIH Grant/Contract )
First Posted: August 30, 2013    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018

Keywords provided by David Huang, Oregon Health and Science University:
IOP
Glaucoma
Trabeculectomy

Additional relevant MeSH terms:
Glaucoma
Ocular Hypertension
Eye Diseases