Intraocular Pressure DisorderNCT01737645
A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
An observational study of Intraocular Pressure Disorder, run by Corewell Health East at 1 site in United States.
Trial summary
This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Intraocular Pressure Disorder
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2012to Jul 2014
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult Subjects undergoing prolonged procedures expected to be in steep Trendelenburg position. Procedure must be scheduled for > 3 hours, eg. robotic prostatectomy, hysterectomy, and cystectomy.
Who may be able to join
- Subjects undergoing prolonged procedures (scheduled >3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
- Morbidly obese subjects: BMI ≥ 35 kg/m2
- Thin subjects: BMI ≤ 30 kg/m2
- Age 18-70
- ASA (American Society of Anesthesiologists) physical status classification I, II, or III
Who cannot join
- Known history of glaucoma
- Note:if initial IOP is noted to be >21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed.
- Recent use of IOP lowering topical ophthalmic agents
- Allergy to latex or proparacaine hydrochloride ophthalmic solution
- Patients with active corneal epithelial defects or history of recurrent corneal erosion
- Patients with underlying disorders that can directly increase intraocular pressure (thyroid eye disease, intra orbital tumors, orbital vascular malformation, Sturge-Weber disease, carotid or dural cavernous arteriovenous malformation, cavernous sinus pathology)
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- History of corneal surgery, to include LASIK (laser-assisted in-situ keratomileusis)
- Any eye surgery within prior 1 month
- Known pregnancy
- Cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
William Beaumont Hospital
Royal Oak, Michigan, 48073
About this study
This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.
Read the detailed description
Eye pressure will be measured at protocol specified intervals.
- Conditions
- Intraocular Pressure Disorder
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 |
|---|---|---|
| obese patients | BMI (body mass index) more than or equal to 35 kg/m2 (weight in kilograms divided by the square of the height in metres) | |
| Thin patients | BMI less than or equal to 30 kg/m2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.
Measured: Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.
Secondary outcomes (2)
To determine rate of rise of IOP during steep Trendelenburg positioning
Measured: The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.
To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.
Measured: The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2014
- Study completionJul 2014
Why it stopped: Difficulty in enrolling subjects.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intraocular Pressure DisorderStudies of the same condition, open and under way.
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roy Soto, MD, Corewell Health East
- Investigators
- Roy G Soto, MD, Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01737645
- Sponsor's protocol ID
- 2011-273
- Status last verified
- Jul 2014
- First submitted
- 16 Mar 2012
- Last updated
- 17 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Intraocular Pressures (IOP) During Prolonged Trendelenburg Positioning in Morbidly Obese and Thin Patients
- ClinicalTrials.gov ID
- NCT01737645
- Acronym / sponsor ID
- 2011-273
- Conditions
- Intraocular Pressure Disorder
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Difficulty in enrolling subjects.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 29 Nov 2012 (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.
This study is to determine if there is a rise in eye pressure, when patients are placed in a position where the head is lower than the rest of the body during long surgeries.
Detailed description
Eye pressure will be measured at protocol specified intervals.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| obese patients | – | –BMI (body mass index) more than or equal to 35 kg/m2 (weight in kilograms divided by the square of the height in metres) |
| Thin patients | – | –BMI less than or equal to 30 kg/m2 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Subjects undergoing prolonged procedures expected to be in steep Trendelenburg position. Procedure must be scheduled for > 3 hours, eg. robotic prostatectomy, hysterectomy, and cystectomy.
Key inclusion criteria (5 listed)
- Subjects undergoing prolonged procedures (scheduled >3hr) in steep Trendelenburg position (eg. robotic prostatectomy, hysterectomy, cystectomy)
- Morbidly obese subjects: BMI ≥ 35 kg/m2
- Thin subjects: BMI ≤ 30 kg/m2
- Age 18-70
- ASA (American Society of Anesthesiologists) physical status classification I, II, or III
Key exclusion criteria (10 listed)
- Known history of glaucoma
- Note:if initial IOP is noted to be >21mmHg (millimeters of mercury), patient will be excluded from study and an ophthalmology consultation will be obtained.Surgery will not be postponed.
- Recent use of IOP lowering topical ophthalmic agents
- Allergy to latex or proparacaine hydrochloride ophthalmic solution
- Patients with active corneal epithelial defects or history of recurrent corneal erosion
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
To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects.
Time frame: Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.
2 secondary outcomes
To determine rate of rise of IOP during steep Trendelenburg positioning
Time frame: The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.
To compare peak IOP and rise of IOP during steep Trendelenburg positioning in thin vs morbidly obese subjects.
Time frame: The time during the surgery when the patient is in steep Trendelenburg positioning. The overall time frame for which the outcome measure is assessed is up to 3 years.
Results and safety
The study was stopped early (reason given: Difficulty in enrolling subjects.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2014.
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.
Roy G Soto, MD principal investigator
Corewell Health East
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 Disorder, run by Corewell Health East 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 5 inclusion and 10 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: stopped early, as of the sponsor's last update on 17 Jul 2014. 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 stopped early (reason given: Difficulty in enrolling subjects.). Results are not available in the source record.
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?
To compare the percent change from baseline IOP reading to the peak IOP reading during steep Trendelenburg positioning in thin subjects vs morbidly obese subjects. (time frame: Measured from baseline IOP to peak IOP during steep Trendelenburg. The overall time frame for which the outcome measure is assessed is up to 3 years.). 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 17 Jul 2014.