Intraocular PressureIOPNCT00837226
Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure (IOP)
An observational study of Intraocular Pressure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Sep 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Minimally Invasive Surgeons of Texas
Bellaire, Texas, 77401
About this study
Official title: 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.
- Conditions
- Intraocular Pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group-Bariatric procedure performed | Not described | |
| Control group: No bariatric procedures | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
Measured: Data will be recorded the same day when a patient comes to the clinic.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startSep 2010
- Primary completionSep 2010 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular PressureStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Feldman, The University of Texas Health Science Center, Houston
- Investigators
- Robert Feldman, M.D., Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837226
- Sponsor's protocol ID
- 08-0499
- Acronym
- IOP
- Status last verified
- Dec 2015
- First submitted
- 4 Feb 2009
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Weight Loss From Bariatric Surgery on Intraocular Pressure
- ClinicalTrials.gov ID
- NCT00837226
- Acronym / sponsor ID
- IOP / 08-0499
- Conditions
- Intraocular Pressure
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Sep 2010 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group-Bariatric procedure performed | – | – |
| Control group: No bariatric procedures | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Intraocular pressure
Time frame: Data will be recorded the same day when a patient comes to the clinic.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Feldman, M.D. principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intraocular Pressure, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 8 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: Data will be recorded the same day when a patient comes to the clinic.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2015; AzTrials last refreshed its copy on 8 Nov 2026.