Eye Pressure Lowering Surgery | NCT01931904

Studies
Eye Pressure Lowering Surgery

NCT01931904

Sponsor

Oregon Health and Science University

Status

Unknown status

Last Update Posted

Apr 18, 2023Actual

Enrollment

46Estimated

Phase

Not provided

Conditions

Glaucoma

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1R01EY023285	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 1, 2014Actual

Primary Completion Date

May 2026Estimated

Completion Date

May 2026Estimated

First Submitted Date

Aug 27, 2013

First Submission Date that Met QC Criteria

Aug 29, 2013

First Posted Date

Aug 30, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 17, 2023

Last Update Posted Date

Apr 18, 2023Actual

Name	Class
National Eye Institute (NEI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Estimated

Label	Type	Description	Intervention Names
Trabeculectomy or Tube Shunt Patients		46 glaucoma patients undergoing trabeculectomy or tube shunt surgery to lower IOP

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Effects of Intraocular Pressure (IOP) Reduction on Ocular Perfusion	To determine if IOP reduction improves ocular perfusion. Change in IOP reduction will be measured in mmHg.	Subjects will be evaluated on enrollment (pre-operatively) and at post-operative visits ( 3, 6, 12, 18, and 24-months post-op).

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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 >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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

This study will measure blood flow changes in 46 glaucoma patients undergoing trabeculectomy or shunt surgery to lower IOP.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chinmay Deshpande, M.Optom.	Contact	503-494-9628		deshpanc@ohsu.edu
Denny Romfh, OD	Contact	503-494-4351		romfhd@ohsu.edu

Overall Officials

Name	Affiliation	Role
Aiyin Chen, MD	Oregon Health and Science University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
OHSU	Recruiting	Portland	Oregon	97239	United States

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases