Effects of Weight Loss From Bariatric Surgery on IOP
| Tracking Information | |||||
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| First Received Date ICMJE | February 4, 2009 | ||||
| Last Updated Date | September 30, 2010 | ||||
| Start Date ICMJE | September 2010 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Intraocular pressure [ Time Frame: Data will be recorded the same day when a patient comes to the clinic. ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00837226 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effects of Weight Loss From Bariatric Surgery on IOP | ||||
| Official Title ICMJE | The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure | ||||
| 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. |
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| Condition ICMJE | Intraocular Pressure | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Withdrawn | ||||
| Estimated Enrollment ICMJE | 100 | ||||
| Estimated Completion Date | September 2010 | ||||
| Estimated Primary Completion Date | September 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00837226 | ||||
| Other Study ID Numbers ICMJE | 08-0499 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Robert Feldman, University of Texas Health Science Center-Houston | ||||
| Study Sponsor ICMJE | The University of Texas Health Science Center, Houston | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | The University of Texas Health Science Center, Houston | ||||
| Verification Date | September 2010 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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