Intraocular PressureNCT00593359
Intraocular Pressure During Spine Surgery
An observational study of Intraocular Pressure, run by The Cleveland Clinic at 1 site in United States.
Trial summary
This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups: Group A - Lactated Ringer's replacement for blood loss and placebo eye drops Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops Group C - Albumin replacement for… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Intraocular Pressure
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to Feb 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing spinal surgery in the prone position for at least 5 hours.
Who may be able to join
- Spine surgery with instrumentation in prone position expected to last at least 5 hours;
- Anticipated blood loss ≥ 1L
- Age 18-80 years old;
- ASA physical status I-III.
Who cannot join
- History of increased intraocular pressure or glaucoma;
- Diabetic retinopathy;
- Heart failure or serious left ventricular dysfunction;
- Abnormal preoperative fundus examination;
- Creatinine > 2 mg/dL;
- Patient refuses blood transfusion or albumin administration
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Lactated Ringer's Solution Versus Albumin and the Alpha-2 Agonist Brimonidine Versus Placebo on Intraocular Pressure During Prone Spine Surgery
This study will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:
Group A - Lactated Ringer's replacement for blood loss and placebo eye drops
Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops
Group C - Albumin replacement for blood loss and placebo eye drops
Group D - Albumin replacement for blood loss and brimonidine eye drops
Read the detailed description
Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.
- Conditions
- Intraocular Pressure
- Keywords
- Spinal surgery, Prone spinal surgery
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 |
|---|---|---|
| A | Lactated Ringer's replacement for blood loss and placebo eye drops | |
| B | Lactated Ringer's replacement for blood loss and brimonidine eye drops | |
| C | Albumin replacement for blood loss and placebo eye drops; | |
| D | Albumin replacement for blood loss and brimonidine eye drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome will be the maximum intraocular pressure at any time during surgery.
Measured: 15 days post surgery
Secondary outcomes (1)
Intraocular pressure as a function of surgical duration; Velocity of retrobulbar blood flow; Facial edema and or chemosis; Time to extubation; Duration of recovery Correlation between Dpp and FTc.
Measured: 15 days post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study startDec 2007
- Primary completionFeb 2010
- Study completionFeb 2010
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 Cleveland ClinicThe 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Daniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00593359
- Sponsor's protocol ID
- 07-571
- Status last verified
- Feb 2016
- First submitted
- 2 Jan 2008
- Last updated
- 23 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Lactated Ringer's Solution Versus Albumin and the Alpha-2 Agonist Brimonidine Versus Placebo on Intraocular Pressure During Prone Spine Surgery
- ClinicalTrials.gov ID
- NCT00593359
- Acronym / sponsor ID
- 07-571
- Conditions
- Intraocular Pressure
- Keywords
- Spinal surgery, Prone spinal surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 15 Jan 2008 (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 will compare the effect of two intravenous solutions on eye pressure during spine surgery in the following groups:
Group A - Lactated Ringer's replacement for blood loss and placebo eye drops
Group B - Lactated Ringer's replacement for blood loss and brimonidine eye drops
Group C - Albumin replacement for blood loss and placebo eye drops
Group D - Albumin replacement for blood loss and brimonidine eye drops
Detailed description
Patients will be administered either brimonidine eye drops, or placebo eye drops, preoperatively, on the day of surgery and during surgery. Eye pressure will be measured before surgery, every 30 minutes throughout your surgery and every hour for 4 hours following surgery. Subjects will be evaluated before surgery and on days 5, 8, 15 after surgery. During these evaluations, the subject will be asked questions about recovery and his/her eyes will be checked by an ophthalmologist and vision will be tested.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| A | – | –Lactated Ringer's replacement for blood loss and placebo eye drops |
| B | – | –Lactated Ringer's replacement for blood loss and brimonidine eye drops |
| C | – | –Albumin replacement for blood loss and placebo eye drops; |
| D | – | –Albumin replacement for blood loss and brimonidine eye drops |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing spinal surgery in the prone position for at least 5 hours.
Key inclusion criteria (4 listed)
- Spine surgery with instrumentation in prone position expected to last at least 5 hours;
- Anticipated blood loss ≥ 1L
- Age 18-80 years old;
- ASA physical status I-III.
Key exclusion criteria (6 listed)
- History of increased intraocular pressure or glaucoma;
- Diabetic retinopathy;
- Heart failure or serious left ventricular dysfunction;
- Abnormal preoperative fundus examination;
- Creatinine > 2 mg/dL;
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
The primary outcome will be the maximum intraocular pressure at any time during surgery.
Time frame: 15 days post surgery
1 secondary outcome
Intraocular pressure as a function of surgical duration; Velocity of retrobulbar blood flow; Facial edema and or chemosis; Time to extubation; Duration of recovery Correlation between Dpp and FTc.
Time frame: 15 days post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2016.
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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.
Daniel I Sessler, MD study chair
The Cleveland Clinic
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 Cleveland Clinic 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 23 Feb 2016. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The primary outcome will be the maximum intraocular pressure at any time during surgery. (time frame: 15 days post surgery). 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 23 Feb 2016.