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This study has been withdrawn prior to enrollment.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
  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

Resource links provided by NLM:


Further study details as provided by The University of Texas Health Science Center, Houston:

Primary Outcome Measures:
  • 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
Study Population

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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00837226

Locations
United States, Texas
Minimally Invasive Surgeons of Texas
Bellaire, Texas, United States, 77401
Sponsors and Collaborators
The University of Texas Health Science Center, Houston
Investigators
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 July 22, 2014