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
Sponsor:
Collaborator:
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
Information provided by:
Hospital Universitario Ramon y Cajal
ClinicalTrials.gov Identifier:
NCT00993174
First received: October 9, 2009
Last updated: June 24, 2011
Last verified: May 2010
  Purpose

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
Esotropia
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

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00993174

Locations
Spain
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
  More Information

No publications provided

Responsible Party: Jaime Tejedor, Hospital Ramón y Cajal
ClinicalTrials.gov 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:
Esotropia
Strabismus
Ocular Motility Disorders
Cranial Nerve Diseases
Nervous System Diseases
Eye Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 19, 2014