Effects of Weight Loss From Bariatric Surgery on IOP
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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.
| Condition |
|---|
|
Intraocular Pressure |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure |
- Intraocular pressure [ Time Frame: Data will be recorded the same day when a patient comes to the clinic. ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2010 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
| Study group-Bariatric procedure performed |
| Control group: No bariatric procedures |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
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
Contacts and Locations| United States, Texas | |
| Minimally Invasive Surgeons of Texas | |
| Bellaire, Texas, United States, 77401 | |
| Principal Investigator: | Robert Feldman, M.D. | The University of Texas Health Science Center, Houston |
More Information
No publications provided
| Responsible Party: | Dr. Robert Feldman, University of Texas Health Science Center-Houston |
| ClinicalTrials.gov Identifier: | NCT00837226 History of Changes |
| Other Study ID Numbers: | 08-0499 |
| Study First Received: | February 4, 2009 |
| Last Updated: | September 30, 2010 |
| Health Authority: | United States: Institutional Review Board |
Additional relevant MeSH terms:
|
Weight Loss Body Weight Changes Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013