One-stage Adjustable Strabismus Surgery Under AIVOC

NCT04261699 | Completed

• 1 other identifier: LOCAL2019-EL01
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

Brief 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)

Conditions

Strabismus; Surgery

Keywords

Adjustable strabismus surgery; Target-controlled infusion of Propofol-Reminfentanyl

Outcome Measures

Primary Outcomes (1)

• Need for a second adjustement time

  Use of a second adjustment time the day after surgery

  The day after the intervention

Secondary Outcomes (3)

• Digital visual scale to assess pain of patient

  Before the intervention, before the intervention and one month after the intervention

• Patient comfort assessment questionnaire

  5 minutes after the end of the intervention

• Patient satisfaction questionnaire

  5 minutes after the end of the intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Clinique Saint Jean, France: lead

Study Sites (1)

Clinique Saint Jean

Montpellier, Hérault, 34000, France

Location

Related Publications (11)

• 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.

  PMID: 1420063 BACKGROUND

• 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.

  PMID: 29527670 BACKGROUND

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

  PMID: 10977229 BACKGROUND

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

  PMID: 10150815 BACKGROUND

• 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.

  PMID: 11249243 BACKGROUND

• 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.

  PMID: 10358813 BACKGROUND

• 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.

  PMID: 26743186 BACKGROUND

• 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.

  PMID: 19204411 BACKGROUND

• 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.

  PMID: 15255366 BACKGROUND

• 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.

  PMID: 15956950 BACKGROUND

• 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.

  PMID: 15616499 BACKGROUND

MeSH Terms

Conditions

Strabismus

Condition Hierarchy (Ancestors)

Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• Erick LAURENT, MD

  Clinique Saint Jean, Montpellier

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: January 28, 2020
• Primary Completion: June 30, 2021
• Study Completion: July 31, 2021
• Last Updated: August 25, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)