Surgery for Esotropia Under Topical Anesthesia (SETTA)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Hospital Universitario Ramon y Cajal.
Recruitment status was  Active, not recruiting
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Information provided by:
Hospital Universitario Ramon y Cajal Identifier:
First received: October 9, 2009
Last updated: June 24, 2011
Last verified: May 2010
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 Intervention
Procedure: Topical strabismus surgery
Procedure: Sub-Tenon's strabismus surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Amount of Surgery for Esotropia Under Topical Anesthesia

Resource links provided by NLM:

Further study details as provided by Hospital Universitario Ramon y Cajal:

Primary Outcome Measures:
  • Amount of surgery required in mm and mm/degree of deviation angle [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Motor (deviation angle) and stereoacuity outcome [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: May 2004
Estimated Study Completion Date: June 2013
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   15 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00993174

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

Responsible Party: Jaime Tejedor, Hospital Ramón y Cajal Identifier: NCT00993174     History of Changes
Other Study ID Numbers: SETTA 
Study First Received: October 9, 2009
Last Updated: June 24, 2011
Health Authority: Spain: Spanish Agency of Medicines

Additional relevant MeSH terms:
Cranial Nerve Diseases
Eye Diseases
Nervous System Diseases
Ocular Motility Disorders
Central Nervous System Depressants
Physiological Effects of Drugs processed this record on May 26, 2016