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

The University of Texas System (UT) logo

The University of Texas System (UT)

Status

Withdrawn

Conditions

Intraocular Pressure

Study type

Observational

Funder types

Other

Identifiers

NCT00837226
08-0499

Details and patient eligibility

About

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.

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

0 participants in 2 patient groups

Study group-Bariatric procedure performed
Control group: No bariatric procedures

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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