Effects of Weight Loss From Bariatric Surgery on IOP

This study has been withdrawn prior to enrollment.
Sponsor:
Information provided by:
The University of Texas Health Science Center, Houston
ClinicalTrials.gov Identifier:
NCT00837226
First received: February 4, 2009
Last updated: September 30, 2010
Last verified: September 2010

February 4, 2009
September 30, 2010
September 2010
September 2010   (final data collection date for primary outcome measure)
Intraocular pressure [ Time Frame: Data will be recorded the same day when a patient comes to the clinic. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00837226 on ClinicalTrials.gov Archive Site
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Effects of Weight Loss From Bariatric Surgery on IOP
The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure

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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Observational
Time Perspective: Prospective
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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.

Intraocular Pressure
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  • Study group-Bariatric procedure performed
  • Control group: No bariatric procedures
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
100
September 2010
September 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00837226
08-0499
No
Dr. Robert Feldman, University of Texas Health Science Center-Houston
The University of Texas Health Science Center, Houston
Not Provided
Principal Investigator: Robert Feldman, M.D. The University of Texas Health Science Center, Houston
The University of Texas Health Science Center, Houston
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP