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Surgery for Esotropia Under Topical Anesthesia (SETTA)

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ClinicalTrials.gov Identifier: NCT00993174
Recruitment Status : Unknown
Verified May 2010 by Hospital Universitario Ramon y Cajal.
Recruitment status was:  Active, not recruiting
First Posted : October 12, 2009
Last Update Posted : June 27, 2011
Information provided by:

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
Esotropia Procedure: Topical strabismus surgery Procedure: Sub-Tenon's strabismus surgery

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated 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 2004
Primary Completion Date : June 2009
Estimated Study Completion Date : June 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

Outcome Measures

Primary Outcome Measures :
  1. Amount of surgery required in mm and mm/degree of deviation angle [ Time Frame: Immediate ]

Secondary Outcome Measures :
  1. Motor (deviation angle) and stereoacuity outcome [ Time Frame: 6 months ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
ClinicalTrials.gov Identifier: NCT00993174     History of Changes
Other Study ID Numbers: SETTA
First Posted: October 12, 2009    Key Record Dates
Last Update Posted: June 27, 2011
Last Verified: May 2010

Additional relevant MeSH terms:
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Central Nervous System Depressants
Physiological Effects of Drugs