Overview

This trial is active, not recruiting.

Condition esotropia
Treatments topical strabismus surgery, sub-tenon's strabismus surgery
Sponsor Hospital Universitario Ramon y Cajal
Collaborator Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Start date May 2004
End date June 2009
Trial size 60 participants
Trial identifier NCT00993174, SETTA

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)
topical strabismus surgery
Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
(Active Comparator)
Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)
sub-tenon's strabismus surgery
Surgery is carried out after sub-Tenon's injection of xylocaine

Primary Outcomes

Measure
Amount of surgery required in mm and mm/degree of deviation angle
time frame: Immediate

Secondary Outcomes

Measure
Motor (deviation angle) and stereoacuity outcome
time frame: 6 months

Eligibility Criteria

Male or female participants from 15 years up to 60 years old.

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

Additional Information

Official title Amount of Surgery for Esotropia Under Topical Anesthesia
Principal investigator Jaime Tejedor, MD, PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2011.
Information provided to ClinicalTrials.gov by Hospital Universitario Ramon y Cajal.