Surgery for Esotropia Under Topical Anesthesia (SETTA)

June 24, 2011 updated by: Hospital Universitario Ramon y Cajal

Amount of Surgery for Esotropia Under Topical Anesthesia

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28034
        • Hospital Univ Ramón y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 60 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Topical anesthesia
Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)
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)
Surgery is carried out after sub-Tenon's injection of xylocaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Amount of surgery required in mm and mm/degree of deviation angle
Time Frame: Immediate
Immediate

Secondary Outcome Measures

Outcome Measure
Time Frame
Motor (deviation angle) and stereoacuity outcome
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jaime Tejedor, MD, PhD, Hospital Universitario Ramón y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Primary Completion (ACTUAL)

June 1, 2009

Study Completion (ANTICIPATED)

June 1, 2013

Study Registration Dates

First Submitted

October 9, 2009

First Submitted That Met QC Criteria

October 9, 2009

First Posted (ESTIMATE)

October 12, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

June 27, 2011

Last Update Submitted That Met QC Criteria

June 24, 2011

Last Verified

May 1, 2010

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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