Intraocular PressureNCT03097705
Effect of Steep Trendelenburg in Laparoscopic Surgery on IOP & RNFL Thickness
A study testing OCT (Optical coherence tomography) in people with Intraocular Pressure and Retinal Nerve Fiber Bundle Deficiency, run by Carmel Medical Center.
Trial summary
The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery Read more about this study
- Who is it for?
- Ages 40 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Intraocular Pressure, Retinal Nerve Fiber Bundle Deficiency
- What is being tested?
- OCT (Optical coherence tomography)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 20 Apr 2017to 12 Mar 2018
- Phase
- Interventional
- 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 40 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES
Who cannot join
- SUBJECT WITH EYES DISEASE
- PREGNANCY DURING THE STUDY PERIOD
About this study
Official title: The Effect of Steep Trendelenburg Position Used During Laparoscopic Surgery on Intraocular Pressure During Surgery and on the Retinal Nerve Fiber Thickness After Surgery
The effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery
Read the detailed description
To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation
- Being tested
- OCT (Optical coherence tomography)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT (Optical coherence tomography)Diagnostic test
Also called CARE (ICARE FINLAND Oy)
RNFL AND IOP MEASUREMNTS
| Study group | Role | What they receive |
|---|---|---|
| IOP and OCT RNFL measurements | Other | all subjects will undergo ophthalmological exams including IOP and RNFL OCT measurements Receives: Diagnostic Test: OCT (Optical coherence tomography) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra Ocular Pressure (IOP)
IOP measurement will be taken before, during and after surgery using ICARE tonometer
Measured: Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery
Retinal Nerve Fiber Layer Thickness (RNFL) using OCT
RNFL measurement will be taken before and after surgery using spectralis OCT
Measured: Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2017
- Study start20 Apr 2017 (estimated)
- Primary completion12 Sep 2017 (estimated)
- Study completion12 Mar 2018 (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.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Orna Geyer, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03097705
- Sponsor's protocol ID
- CMC-17-0026-CTIL
- Status last verified
- Mar 2017
- First submitted
- 8 Mar 2017
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Steep Trendelenburg Position Used During Laparoscopic Surgery on Intraocular Pressure During Surgery and on the Retinal Nerve Fiber Thickness After Surgery
- ClinicalTrials.gov ID
- NCT03097705
- Acronym / sponsor ID
- CMC-17-0026-CTIL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Study start
- 20 Apr 2017 (estimated)
- Primary completion
- 12 Sep 2017 (estimated)
- Study completion
- 12 Mar 2018 (estimated)
- First posted
- 31 Mar 2017 (actual)
- 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 effect of Steep Trendelenburg position used during laparoscopic surgery on intraocular pressure during surgery and on the retinal nerve fiber thickness after surgery
Detailed description
To measure IOP and RNFL thickness in subjects undergoing laparoscopic operations in steep trendelenburg before, during, and after the operation
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IOP and OCT RNFL measurements | Other | Diagnostic Test: OCT (Optical coherence tomography)all subjects will undergo ophthalmological exams including IOP and RNFL OCT measurements |
Who may qualify
- Ages
- 40 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- SUBJECTS INTENDING TO UNDERGO LAPROSCOPIC SERGURY WHICH HAVE NO EYE DISEASES
Key exclusion criteria (2 listed)
- SUBJECT WITH EYES DISEASE
- PREGNANCY DURING THE STUDY PERIOD
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT (Optical coherence tomography)Also: CARE (ICARE FINLAND Oy)RNFL AND IOP MEASUREMNTS | Diagnostic test | IOP and OCT RNFL measurements |
Primary outcome
Intra Ocular Pressure (IOP)
Time frame: Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery
IOP measurement will be taken before, during and after surgery using ICARE tonometer
Retinal Nerve Fiber Layer Thickness (RNFL) using OCT
Time frame: Change in OCT RNFL thickness from baseline to OCT RNFL thickness during surgery and to one week and to three months following surgery
RNFL measurement will be taken before and after surgery using spectralis OCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OCT (Optical coherence tomography) in people with Intraocular Pressure and Retinal Nerve Fiber Bundle Deficiency, run by Carmel Medical Center.
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 2 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: status not confirmed, as of the sponsor's last update on 31 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Intra Ocular Pressure (IOP) (time frame: Change in IOP from baseline to IOP during surgery and to one week and to three months following surgery). The study lists 2 primary outcomes in all. 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 31 Mar 2017.