Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP)

NCT00837226 | Withdrawn

• 1 other identifier: 08-0499
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Intraocular Pressure

Outcome Measures

Primary Outcomes (1)

• Intraocular pressure

  Data will be recorded the same day when a patient comes to the clinic.

Study Arms (2)

Study group-Bariatric procedure performed

Control group: No bariatric procedures

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

Minimally Invasive Surgeons of Texas

Bellaire, Texas, 77401, United States

Location

Study Officials

• Robert Feldman, M.D.

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ◦Clinical Professor and Chair and Richard S. Ruiz, M.D., Distinguished University Chair in Ophthalmology

Study Record Dates

• First Submitted: February 4, 2009
• First Posted: February 5, 2009
• Study Start: September 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: December 8, 2015

Record last verified: 2015-12

Locations

US (1)