Surgery for Esotropia Under Topical Anesthesia
Not Applicable
- Conditions
- Esotropia
- Interventions
- Procedure: Topical strabismus surgeryProcedure: Sub-Tenon's strabismus surgery
- Registration Number
- NCT00993174
- Lead Sponsor
- Hospital Universitario Ramon y Cajal
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Topical anesthesia Topical strabismus surgery Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel) Sub-Tenon's anesthesia Sub-Tenon's strabismus surgery Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)
- Primary Outcome Measures
Name Time Method Amount of surgery required in mm and mm/degree of deviation angle Immediate
- Secondary Outcome Measures
Name Time Method Motor (deviation angle) and stereoacuity outcome 6 months
Trial Locations
- Locations (1)
Hospital Univ Ramón y Cajal
🇪🇸Madrid, Spain