- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00993174
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
Status
Unknown
Conditions
Intervention / Treatment
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
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Madrid, Spain, 28034
- Hospital Univ Ramón y Cajal
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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 |
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EXPERIMENTAL: Topical anesthesia
Patients undergo strabismus surgery for esotropia using topical anesthesia (instillation of drops plus gel)
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Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure
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ACTIVE_COMPARATOR: Sub-Tenon's anesthesia
Patients undergo surgery for strabismus (esotropia) using sub-Tenon's administration of anesthetic (xylocaine)
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Surgery is carried out after sub-Tenon's injection of xylocaine
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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
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Immediate
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Motor (deviation angle) and stereoacuity outcome
Time Frame: 6 months
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6 months
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- SETTA
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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