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Surgery for Esotropia Under Topical Anesthesia (SETTA)

Primary Purpose

Esotropia

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Topical strabismus surgery
Sub-Tenon's strabismus surgery
Sponsored by
Hospital Universitario Ramon y Cajal
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Esotropia

Eligibility Criteria

15 Years - 60 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Univ Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Topical anesthesia

Sub-Tenon's anesthesia

Arm Description

Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)

Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)

Outcomes

Primary Outcome Measures

Amount of surgery required in mm and mm/degree of deviation angle

Secondary Outcome Measures

Motor (deviation angle) and stereoacuity outcome

Full Information

First Posted
October 9, 2009
Last Updated
June 24, 2011
Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
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1. Study Identification

Unique Protocol Identification Number
NCT00993174
Brief Title
Surgery for Esotropia Under Topical Anesthesia
Acronym
SETTA
Official Title
Amount of Surgery for Esotropia Under Topical Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
May 2004 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
June 2013 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Universitario Ramon y Cajal
Collaborators
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Esotropia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Topical anesthesia
Arm Type
Experimental
Arm Description
Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)
Arm Title
Sub-Tenon's anesthesia
Arm Type
Active Comparator
Arm Description
Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)
Intervention Type
Procedure
Intervention Name(s)
Topical strabismus surgery
Intervention Description
Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
Intervention Type
Procedure
Intervention Name(s)
Sub-Tenon's strabismus surgery
Intervention Description
Surgery is carried out after sub-Tenon's injection of xylocaine
Primary Outcome Measure Information:
Title
Amount of surgery required in mm and mm/degree of deviation angle
Time Frame
Immediate
Secondary Outcome Measure Information:
Title
Motor (deviation angle) and stereoacuity outcome
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jaime Tejedor, MD, PhD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Univ Ramón y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain

12. IPD Sharing Statement

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Surgery for Esotropia Under Topical Anesthesia

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