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NCT00837226 Clinical Trial

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

Intraocular Pressure Clinical Trial

— IOP  

Official title:
The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure

Clinical Trial Details — Status: Withdrawn

Administrative data
NCT number NCT00837226
Other study ID # 08-0499
Secondary ID
Status Withdrawn
Phase N/A
First received February 4, 2009
Last updated December 4, 2015
Start date September 2010
Est. completion date September 2010

Study information
Verified date December 2015
Source The University of Texas Health Science Center, Houston
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Withdrawn
Enrollment 0
Est. completion date September 2010
Est. primary completion date September 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Minimally Invasive Surgeons of Texas Bellaire Texas

Sponsors (1)
Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure Data will be recorded the same day when a patient comes to the clinic. No
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