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Surgery for Esotropia Under Topical Anesthesia

Amount of Surgery for Esotropia Under Topical Anesthesia

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00993174
Acronym
SETTA
Enrollment
60
Registered
2009-10-12
Start date
2004-05-31
Completion date
2013-06-30
Last updated
2011-06-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Esotropia

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.

Interventions

PROCEDURETopical strabismus surgery

Surgery is carried out after instilling drops for anesthesia and administering lidocaine gel during the procedure

PROCEDURESub-Tenon's strabismus surgery

Surgery is carried out after sub-Tenon's injection of xylocaine

Sponsors

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
CollaboratorOTHER
Hospital Universitario Ramon y Cajal
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
15 Years to 60 Years
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

Design outcomes

Primary

MeasureTime frame
Amount of surgery required in mm and mm/degree of deviation angleImmediate

Secondary

MeasureTime frame
Motor (deviation angle) and stereoacuity outcome6 months

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026