Surgery for Esotropia Under Topical Anesthesia

Esotropia Clinical Trial

— SETTA  

Official title:

Amount of Surgery for Esotropia Under Topical Anesthesia

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00993174
• Other study ID #: SETTA
• Status: Active, not recruiting
• Phase: N/A
• First received: October 9, 2009
• Last updated: June 24, 2011
• Start date: May 2004
• Est. completion date: June 2013

Study information

• Verified date: May 2010
• Source: Hospital Universitario Ramon y Cajal
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial Summary

Adult patients requiring surgery for esotropia will be randomized to surgery under topical anesthesia or sub-Tenon's anesthesia. Amount of surgery required with the two anesthetic procedures will be compared. Motor and sensory outcome of the two treatment groups will also be compared.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: June 2013
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• Esotropia deviation angle equal to or lower than 45 prism dioptres (requiring one or two-muscle surgery)

• Visual acuity at least 20/40 in each eye

• Cooperation for topical anesthesia

Exclusion Criteria:

• Paretic or restrictive strabismus

• Previous eye muscle surgery

• Significant eye disease other than strabismus

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esotropia

Intervention

Procedure:
• Topical strabismus surgery
Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
• Sub-Tenon's strabismus surgery
Surgery is carried out after sub-Tenon's injection of xylocaine

Locations

Country	Name	City	State
Spain	Hospital Univ Ramón y Cajal	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Ramon y Cajal	Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of surgery required in mm and mm/degree of deviation angle		Immediate	No
Secondary	Motor (deviation angle) and stereoacuity outcome		6 months	No