Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP) (IOP)
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ClinicalTrials.gov Identifier: NCT00837226
: February 5, 2009
Last Update Posted
: December 8, 2015
The University of Texas Health Science Center, Houston
Information provided by (Responsible Party):
Robert Feldman, The University of Texas Health Science Center, Houston
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.
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Ages Eligible for Study:
18 Years and older (Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients who are included in this study will have been evaluated for bariatric surgery and will meet the current eligibility requirements for bariatric surgery. These requirements include that the patient must have failed dietary therapy and have a BMI(body mass index) greater than 40 kg/m2 without associated comorbidities or have a BMI greater than 35 kg/m2 with associated comorbidities. Eleven subjects who will be evaluated for bariatric surgery but choose not to undergo the surgery will be recruited to serve as controls and to verify the changes in intraocular pressure (IOP) are due to the weight loss. It is expected that the IOP of the control patients will be relatively stable, assuming the patients will not have any other surgery or intervention which could affect the IOP.
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.
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