StrabismusAIVOCNCT04261699
One-stage Adjustable Strabismus Surgery Under AIVOC
An observational study of Strabismus and Surgery, run by Clinique Saint Jean, France at 1 site in France.
Trial summary
The purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type AIVOC (Target-controlled infusion of Propofol-Remifentanyl) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Strabismus, Surgery
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jan 2020to 31 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Major patient requiring a strabismus surgery not having expressed their oppostion to participate in the study and eligible for anesthesia of type AIVOC.
Who may be able to join
- Patient with medical insurance
- Major patient requiring a strabismus surgery
- Patient who received information about study and not having expressed their opposition to participate in the study
Who cannot join
- Minor patient
- Patient participation in another interventional study
- Patient having expressed their opposition to participate in the study
- Patient for whom it is impossible to give informed information
- Patient under the protection of justice, under curatorship ou under tutorship
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type AIVOC (Target-controlled infusion of Propofol-Remifentanyl)
Read the detailed description
Adjustable surgery is a surgical treatment technique for strabismus and oculomotor paralysis well known and widely used around the world. The adjustable surgery is done in 2 steps. The first step, performed under general anesthesia, is practically the same as "classic" strabismus surgery however one or more muscles are fixed by temporary sutures. In a second time once the patient is awake and after a new clinical examination the sutures are adjusted and definitively fixed. The adjustment is sometimes made the same day but more often the day after the first intervention because it requires a state of consciousness close to normal.
Anesthesia type Intravenous Intensity Concentration Anesthesia (AIVOC) allows the realization of a surgery under anesthesia general deep (choice of a cerebral or plasma anesthetic target suitable for surgery) but allows a programmed awakening, very fast in full consciousness, condition of an immediate reliable adjustment practically upon stopping the infusion of the anesthetic agent.
The goal is to present an adjustable surgery technique simplified from a logistical point of view since performed in a single step thanks to the contribution of Intravenous Anesthesia with Concentration Objective (AIVOC) and to show that its results are equivalent to a second deferred time.
- Conditions
- Strabismus, Surgery
- Keywords
- Adjustable strabismus surgery, Target-controlled infusion of Propofol-Reminfentanyl
- Medical subject headings
- Strabismus
What is being measured
The primary outcome is the main question the study is designed to answer.
Need for a second adjustement time
Use of a second adjustment time the day after surgery
Measured: The day after the intervention
Secondary outcomes (3)
Digital visual scale to assess pain of patient
Numeric scale numbered from 0 to 10. 0 : no pain, 10 : worst pain possible
Measured: Before the intervention, before the intervention and one month after the intervention
Patient comfort assessment questionnaire
This is a question to determine the comfort of the patient immediatly after the intervention.
Very comfortable Comfortable Less comfortable Uncomfortable Very uncomfortable
Measured: 5 minutes after the end of the intervention
Patient satisfaction questionnaire
Numeric scale numbered from 0 to 10. 0 : unsatisfied, 10 : very satisfied
Measured: 5 minutes after the end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start28 Jan 2020
- Primary completion30 Jun 2021
- Study completion31 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for StrabismusStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinique Saint Jean, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erick LAURENT, MD, Principal investigator, Clinique Saint Jean, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261699
- Sponsor's protocol ID
- LOCAL2019-EL01
- Acronym
- AIVOC
- Status last verified
- Aug 2021
- First submitted
- 6 Feb 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morris RJ, Luff AJ. Adjustable sutures in squint surgery. Br J Ophthalmol. 1992 Sep;76(9):560-2. doi: 10.1136/bjo.76.9.560. No abstract available.
PubMed 1420063Hassan S, Haridas A, Sundaram V. Adjustable versus non-adjustable sutures for strabismus. Cochrane Database Syst Rev. 2018 Mar 12;3(3):CD004240. doi: 10.1002/14651858.CD004240.pub4.
PubMed 29527670Farr AK, Guyton DL. Strabismus after retinal detachment surgery. Curr Opin Ophthalmol. 2000 Jun;11(3):207-10. doi: 10.1097/00055735-200006000-00010.
PubMed 10977229Garrity JA. The surgical management of Graves' ophthalmopathy. Curr Opin Ophthalmol. 1994 Oct;5(5):39-44.
PubMed 10150815Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Ophthalmic Nurs Technol. 2000 May-Jun;19(3):142-7. No abstract available.
PubMed 11249243Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Pediatr Ophthalmol Strabismus. 1999 May-Jun;36(3):112-7; quiz 134-5. doi: 10.3928/0191-3913-19990501-07. No abstract available.
PubMed 10358813Valles-Torres J, Garcia-Martin E, Fernandez-Tirado FJ, Gil-Arribas LM, Pablo LE, Pena-Calvo P. Contact topical anesthesia versus general anaesthesia in strabismus surgery. Arch Soc Esp Oftalmol. 2016 Mar;91(3):108-13. doi: 10.1016/j.oftal.2015.11.012. Epub 2015 Dec 30. English, Spanish.
PubMed 26743186Tatham A, Amaya L. Immediate post-operative adjustable suture strabismus surgery using a target-controlled infusion of propofol-remifentanil. Ophthalmologica. 2009;223(3):192-5. doi: 10.1159/000200766. Epub 2009 Feb 10.
PubMed 19204411Karaba VL, Elibol O. One-stage vs. two-stage adjustable sutures for the correction of esotropia. Strabismus. 2004 Mar;12(1):27-34. doi: 10.1076/stra.12.1.27.29009.
PubMed 15255366Hakim OM, El-Hag YG, Haikal MA. Strabismus surgery under augmented topical anesthesia. J AAPOS. 2005 Jun;9(3):279-84. doi: 10.1016/j.jaapos.2005.01.005.
PubMed 15956950Bleik JH, Karam VY. Comparison of the immediate with the 24-hour postoperative prism and cover measurements in adjustable muscle surgery: is immediate postoperative adjustment reliable? J AAPOS. 2004 Dec;8(6):528-33. doi: 10.1016/j.jaapos.2004.08.004.
PubMed 15616499
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- One-stage Adjustable Strabismus Surgery Under AIVOC
- ClinicalTrials.gov ID
- NCT04261699
- Acronym / sponsor ID
- AIVOC / LOCAL2019-EL01
- Conditions
- Strabismus, Surgery
- Keywords
- Adjustable strabismus surgery, Target-controlled infusion of Propofol-Reminfentanyl
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Clinique Saint Jean, FranceUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 31 Jul 2021 (actual)
- First posted
- 10 Feb 2020 (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 purpose of this study is to note that one-stage adjustable surgery can be enough to provide satisfactory results for the correction of strabismus in adults thanks to the use of an anesthesia type AIVOC (Target-controlled infusion of Propofol-Remifentanyl)
Detailed description
Adjustable surgery is a surgical treatment technique for strabismus and oculomotor paralysis well known and widely used around the world. The adjustable surgery is done in 2 steps. The first step, performed under general anesthesia, is practically the same as "classic" strabismus surgery however one or more muscles are fixed by temporary sutures. In a second time once the patient is awake and after a new clinical examination the sutures are adjusted and definitively fixed. The adjustment is sometimes made the same day but more often the day after the first intervention because it requires a state of consciousness close to normal.
Anesthesia type Intravenous Intensity Concentration Anesthesia (AIVOC) allows the realization of a surgery under anesthesia general deep (choice of a cerebral or plasma anesthetic target suitable for surgery) but allows a programmed awakening, very fast in full consciousness, condition of an immediate reliable adjustment practically upon stopping the infusion of the anesthetic agent.
The goal is to present an adjustable surgery technique simplified from a logistical point of view since performed in a single step thanks to the contribution of Intravenous Anesthesia with Concentration Objective (AIVOC) and to show that its results are equivalent to a second deferred time.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Major patient requiring a strabismus surgery not having expressed their oppostion to participate in the study and eligible for anesthesia of type AIVOC.
Key inclusion criteria (3 listed)
- Patient with medical insurance
- Major patient requiring a strabismus surgery
- Patient who received information about study and not having expressed their opposition to participate in the study
Key exclusion criteria (5 listed)
- Minor patient
- Patient participation in another interventional study
- Patient having expressed their opposition to participate in the study
- Patient for whom it is impossible to give informed information
- Patient under the protection of justice, under curatorship ou under tutorship
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
Need for a second adjustement time
Time frame: The day after the intervention
Use of a second adjustment time the day after surgery
3 secondary outcomes
Digital visual scale to assess pain of patient
Time frame: Before the intervention, before the intervention and one month after the intervention
Patient comfort assessment questionnaire
Time frame: 5 minutes after the end of the intervention
Patient satisfaction questionnaire
Time frame: 5 minutes after the end of the intervention
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 25 Aug 2021.
- Background: PubMed 1420063Morris RJ, Luff AJ. Adjustable sutures in squint surgery. Br J Ophthalmol. 1992 Sep;76(9):560-2. doi: 10.1136/bjo.76.9.560. No abstract available.
- Background: PubMed 29527670Hassan S, Haridas A, Sundaram V. Adjustable versus non-adjustable sutures for strabismus. Cochrane Database Syst Rev. 2018 Mar 12;3(3):CD004240. doi: 10.1002/14651858.CD004240.pub4.
- Background: PubMed 10977229Farr AK, Guyton DL. Strabismus after retinal detachment surgery. Curr Opin Ophthalmol. 2000 Jun;11(3):207-10. doi: 10.1097/00055735-200006000-00010.
- Background: PubMed 10150815Garrity JA. The surgical management of Graves' ophthalmopathy. Curr Opin Ophthalmol. 1994 Oct;5(5):39-44.
- Background: PubMed 11249243Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Ophthalmic Nurs Technol. 2000 May-Jun;19(3):142-7. No abstract available.
- Background: PubMed 10358813Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Pediatr Ophthalmol Strabismus. 1999 May-Jun;36(3):112-7; quiz 134-5. doi: 10.3928/0191-3913-19990501-07. No abstract available.
- Background: PubMed 26743186Valles-Torres J, Garcia-Martin E, Fernandez-Tirado FJ, Gil-Arribas LM, Pablo LE, Pena-Calvo P. Contact topical anesthesia versus general anaesthesia in strabismus surgery. Arch Soc Esp Oftalmol. 2016 Mar;91(3):108-13. doi: 10.1016/j.oftal.2015.11.012. Epub 2015 Dec 30. English, Spanish.
- Background: PubMed 19204411Tatham A, Amaya L. Immediate post-operative adjustable suture strabismus surgery using a target-controlled infusion of propofol-remifentanil. Ophthalmologica. 2009;223(3):192-5. doi: 10.1159/000200766. Epub 2009 Feb 10.
- Background: PubMed 15255366Karaba VL, Elibol O. One-stage vs. two-stage adjustable sutures for the correction of esotropia. Strabismus. 2004 Mar;12(1):27-34. doi: 10.1076/stra.12.1.27.29009.
- Background: PubMed 15956950Hakim OM, El-Hag YG, Haikal MA. Strabismus surgery under augmented topical anesthesia. J AAPOS. 2005 Jun;9(3):279-84. doi: 10.1016/j.jaapos.2005.01.005.
- Background: PubMed 15616499Bleik JH, Karam VY. Comparison of the immediate with the 24-hour postoperative prism and cover measurements in adjustable muscle surgery: is immediate postoperative adjustment reliable? J AAPOS. 2004 Dec;8(6):528-33. doi: 10.1016/j.jaapos.2004.08.004.
- 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.
Erick LAURENT, MD principal investigator
Clinique Saint Jean, Montpellier
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 Strabismus and Surgery, run by Clinique Saint Jean, France at 1 site in France.
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 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 25 Aug 2021. 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 France. 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?
Need for a second adjustement time (time frame: The day after the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04261699, which also lists 11 linked publications.
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 25 Aug 2021.