Eye Pressure Lowering Surgery

NCT ID: NCT01931904

Last Updated: 2023-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-01

Study Completion Date

2026-05-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Glaucoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Trabeculectomy or Tube Shunt Patients

46 glaucoma patients undergoing trabeculectomy or tube shunt surgery to lower IOP

No interventions assigned to this group

Eligibility Criteria

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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
* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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David Huang

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aiyin Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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OHSU

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Chinmay Deshpande, M.Optom.

Role: CONTACT

503-494-9628

Denny Romfh, OD

Role: CONTACT

503-494-4351

Facility Contacts

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Chinmay Deshpande, M.Optom.

Role: primary

503-494-9628

Denny Romfh, OD

Role: backup

503-494-4351

Related Links

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Other Identifiers

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1R01EY023285

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB000009745

Identifier Type: -

Identifier Source: org_study_id

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