Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP)

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

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2010-09-30

Study Completion Date

2010-09-30

Brief Summary

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The purpose of this study is to determine if there is an effect on the eye pressure from extreme weight loss by bariatric procedures. The hypothesis is that excess fat in the orbit of the eye compresses on the outflow system, which causes an elevated eye pressure. This can have many consequences, including the risk for glaucoma. We hope to establish if there is an effect between eye pressure and weight.

Detailed Description

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Conditions

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Intraocular Pressure

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Study group-Bariatric procedure performed

No interventions assigned to this group

Control group: No bariatric procedures

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Age ≥ 18
* Written informed consent obtained
* BMI \> 40 kg/m2 without associated comorbidities or \> 35 kg/m2 with associated comorbidities. In the normal indication for routine bariatric surgery, comorbidities include hypertension, type II diabetes, venous stasis, sleep apnea, polycystic ovary syndrome, pseudotumor cerebri, nonalcoholic steatohepatitis, gastroesophageal reflux disease, coronary artery disease, degenerative joint disease, cancer, and hypercholesterolemia.

Exclusion Criteria

* Current use of systemic steroids
* Any systemic medication which is unstable and can affect IOP
* History or evidence of glaucoma
* Any ocular trauma or ocular surgery
* Outside normal range of corneal thickness (500-600 microns)
* Unable to follow-up for 3 years
* Participating in any investigational device or medication study within 30 days of baseline

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Robert Feldman

◦Clinical Professor and Chair and Richard S. Ruiz, M.D., Distinguished University Chair in Ophthalmology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Feldman, M.D.

Role: PRINCIPAL_INVESTIGATOR

The University of Texas Health Science Center, Houston

Locations

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Minimally Invasive Surgeons of Texas

Bellaire, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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08-0499

Identifier Type: -

Identifier Source: org_study_id