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Effects of Weight Loss From Bariatric Surgery on IOP - NCT00837226-77030(Clinical Trial 269221)



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City:  Houston
State:  
TX
Zip Code: 77030
Conditions: Intraocular Pressure
Purpose: 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.
Study summary:
Criteria: 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
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Data Source: ClinicalTrials.gov
Date Processed: September 22, 2010
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