One-stage Adjustable Strabismus Surgery Under AIVOC

NCT ID: NCT04261699

Last Updated: 2021-08-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

159 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-28

Study Completion Date

2021-07-31

Brief Summary

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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

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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

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Strabismus Surgery

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Clinique Saint Jean, France

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Erick LAURENT, MD

Role: PRINCIPAL_INVESTIGATOR

Clinique Saint Jean, Montpellier

Locations

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Clinique Saint Jean

Montpellier, Hérault, France

Site Status

Countries

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France

References

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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.

Reference Type BACKGROUND
PMID: 1420063 (View on PubMed)

Hassan 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.

Reference Type BACKGROUND
PMID: 29527670 (View on PubMed)

Farr AK, Guyton DL. Strabismus after retinal detachment surgery. Curr Opin Ophthalmol. 2000 Jun;11(3):207-10. doi: 10.1097/00055735-200006000-00010.

Reference Type BACKGROUND
PMID: 10977229 (View on PubMed)

Garrity JA. The surgical management of Graves' ophthalmopathy. Curr Opin Ophthalmol. 1994 Oct;5(5):39-44.

Reference Type BACKGROUND
PMID: 10150815 (View on PubMed)

Strominger MB, Richards R. Adjustable sutures in pediatric ophthalmology and strabismus. J Ophthalmic Nurs Technol. 2000 May-Jun;19(3):142-7. No abstract available.

Reference Type BACKGROUND
PMID: 11249243 (View on PubMed)

Strominger 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.

Reference Type BACKGROUND
PMID: 10358813 (View on PubMed)

Valles-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.

Reference Type BACKGROUND
PMID: 26743186 (View on PubMed)

Tatham 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.

Reference Type BACKGROUND
PMID: 19204411 (View on PubMed)

Karaba 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.

Reference Type BACKGROUND
PMID: 15255366 (View on PubMed)

Hakim 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.

Reference Type BACKGROUND
PMID: 15956950 (View on PubMed)

Bleik 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.

Reference Type BACKGROUND
PMID: 15616499 (View on PubMed)

Other Identifiers

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LOCAL2019-EL01

Identifier Type: -

Identifier Source: org_study_id

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