SETTA: Surgery for Esotropia Under Topical Anesthesia

Sponsor

Hospital Universitario Ramon y Cajal (Other)

Overall Status

Unknown status

CT.gov ID

NCT00993174

Collaborator

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal (Other)

Enrollment

Location

Arms

109

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Esotropia	Procedure: Topical strabismus surgery Procedure: Sub-Tenon's strabismus surgery	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Amount of Surgery for Esotropia Under Topical Anesthesia

Study Start Date :

May 1, 2004

Actual Primary Completion Date :

Jun 1, 2009

Anticipated Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Topical anesthesia Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)	Procedure: Topical strabismus surgery Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
Active Comparator: Sub-Tenon's anesthesia Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)	Procedure: Sub-Tenon's strabismus surgery Surgery is carried out after sub-Tenon's injection of xylocaine

Arm

Intervention/Treatment

Experimental: Topical anesthesia

Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)

Procedure: Topical strabismus surgery

Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure

Active Comparator: Sub-Tenon's anesthesia

Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)

Procedure: Sub-Tenon's strabismus surgery

Surgery is carried out after sub-Tenon's injection of xylocaine

Outcome Measures

Primary Outcome Measures

Amount of surgery required in mm and mm/degree of deviation angle [Immediate]

Secondary Outcome Measures

Motor (deviation angle) and stereoacuity outcome [6 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hospital Univ Ramón y Cajal	Madrid		Spain	28034

Sponsors and Collaborators

Hospital Universitario Ramon y Cajal
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Investigators

Principal Investigator: Jaime Tejedor, MD, PhD, Hospital Universitario Ramon y Cajal

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

, ,

ClinicalTrials.gov Identifier:

NCT00993174

Other Study ID Numbers:

SETTA

First Posted:

Oct 12, 2009

Last Update Posted:

Jun 27, 2011

Last Verified:

May 1, 2010

Additional relevant MeSH terms:

Esotropia

Study Results

No Results Posted as of Jun 27, 2011