BlindnessNCT00875043
Determine the Effect of Intraocular Pressure (IOP), Optic Nerve Imaging, Venous Congestion in Volunteers Prone Position 5 Hours
An observational study of Blindness, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The purpose of this study is to provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. An improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Blindness
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2008to Jul 2008
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- subjects willing to consent
Who cannot join
- individuals unable to tolerate prone position for 5 hours
- individuals unable to tolerate contact lens placement
- females who are pregnant
- individuals with a sensitivity to proparacaine hcl 0.5% or tropicamide 1%
- individuals who are unable to have repeated mesaurements of intaocular pressure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study to Determine the Effect on Intraocular Pressure, Optic Nerve Imaging and Other Markers of Venous Congestion of Volunteer Subjects in the Prone Position for a Period of Five Hours
The purpose of this study is to provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. An improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss.
Read the detailed description
Post operative vision loss resulting from nonocular surgery is a devastating, poorly understood and potentially preventable complication. Ischemic optic neuropathy, affecting both the anterior or posterioir portions of the optic nerve, is the most common cause of postoperative vision loss(POVL). Other, less common causes include retinal artery occlusion, retinal vein occlusion, retinal embolism, and cortical blindness. The estimated incidence of POVL in patients undergoing general anesthesia is 1/60,000. The incidence dramatically increases in cardiopulmonary bypass and prone spine surgery with estimates at 1/1600 and 1/1100, respectively. The etiology is unknown but it is thought to be multifactorial, and several potential risk factors have been identified, including degree of hypotension, preoperative hematocrit, external compression of the eye, blood loss and prone position. The investigators are proposing eight volunteers in two different sessions of 5.5 hours each. The first session the volunteer will lie prone of the flat Jackson table and the second session the volunteer will spend 5 hours prone on the Jackson table with a table elevation of 6 inches. The following measurements will be done: Intraocular Pressure (IOP) with a device called the Tonopen-XL, the Nidex NM 200 to visualize the retinal optic nerve imaging, refractometry, ultrasound, corneal thickness pachymetry, measurement of proptosis, measurement of pupillary reflex, The volunteers do not receive anesthetic medications or intravenous fluids and will provide a baseline for comparision with patients enrolled in the prospective study.
- Conditions
- Blindness
- Keywords
- ischemic optic neuropathy, cortical blindness
- Medical subject headings
- Blindness, Optic Neuropathy, Ischemic, Blindness, Cortical
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 |
|---|---|---|
| 1. flat Jackson table | All measurements previously described will be done with the patient in the prone postion and Jackson table flat. | |
| 2. Elevated Jackson tablet | All measurements previously described will be performed with subjects placed prone on the elevated Jackson table. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies of the same condition, open and under way.
- More trials run by Rutgers, The State University of New JerseyThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Responsible party
- Sponsor
- Investigators
- Geordie P. Grant, MD, Principal investigator, University of Medicine & Dentistry of New Jersey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00875043
- Sponsor's protocol ID
- 0120070324
- Status last verified
- Apr 2009
- First submitted
- 1 Apr 2009
- Last updated
- 14 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Determine the Effect on Intraocular Pressure, Optic Nerve Imaging and Other Markers of Venous Congestion of Volunteer Subjects in the Prone Position for a Period of Five Hours
- ClinicalTrials.gov ID
- NCT00875043
- Acronym / sponsor ID
- 0120070324
- Conditions
- Blindness
- Keywords
- ischemic optic neuropathy, cortical blindness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- Anesthesia Patient Safety Foundation
- Study start
- Mar 2008
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 3 Apr 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 provide data that would give the investigators a better understanding of the physiologic changes that occur and may contribute to post operative blindness. An improved understanding may lead to the development of protocols or devices that reduce the chance of catastrophic visual loss.
Detailed description
Post operative vision loss resulting from nonocular surgery is a devastating, poorly understood and potentially preventable complication. Ischemic optic neuropathy, affecting both the anterior or posterioir portions of the optic nerve, is the most common cause of postoperative vision loss(POVL). Other, less common causes include retinal artery occlusion, retinal vein occlusion, retinal embolism, and cortical blindness. The estimated incidence of POVL in patients undergoing general anesthesia is 1/60,000. The incidence dramatically increases in cardiopulmonary bypass and prone spine surgery with estimates at 1/1600 and 1/1100, respectively. The etiology is unknown but it is thought to be multifactorial, and several potential risk factors have been identified, including degree of hypotension, preoperative hematocrit, external compression of the eye, blood loss and prone position. The investigators are proposing eight volunteers in two different sessions of 5.5 hours each. The first session the volunteer will lie prone of the flat Jackson table and the second session the volunteer will spend 5 hours prone on the Jackson table with a table elevation of 6 inches. The following measurements will be done: Intraocular Pressure (IOP) with a device called the Tonopen-XL, the Nidex NM 200 to visualize the retinal optic nerve imaging, refractometry, ultrasound, corneal thickness pachymetry, measurement of proptosis, measurement of pupillary reflex, The volunteers do not receive anesthetic medications or intravenous fluids and will provide a baseline for comparision with patients enrolled in the prospective study.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1. flat Jackson table | – | –All measurements previously described will be done with the patient in the prone postion and Jackson table flat. |
| 2. Elevated Jackson tablet | – | –All measurements previously described will be performed with subjects placed prone on the elevated Jackson table. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (1 listed)
- subjects willing to consent
Key exclusion criteria (5 listed)
- individuals unable to tolerate prone position for 5 hours
- individuals unable to tolerate contact lens placement
- females who are pregnant
- individuals with a sensitivity to proparacaine hcl 0.5% or tropicamide 1%
- individuals who are unable to have repeated mesaurements of intaocular pressure
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
Not reported in the source record.
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 14 Oct 2016.
- Individual participant dataSharing planned: No
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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.
Geordie P. Grant, MD principal investigator
University of Medicine & Dentistry of New Jersey
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 Blindness, run by Rutgers, The State University of New Jersey 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 1 inclusion and 5 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 14 Oct 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.
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 14 Oct 2016.