Surgery for Esotropia Under Topical Anesthesia (SETTA)

Madrid Health Service

Status: Unknown

Conditions: Esotropia

Treatments: Procedure: Sub-Tenon's strabismus surgery; Procedure: Topical strabismus surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT00993174

SETTA

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 15 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 2 patient groups

Topical anesthesia

Experimental group

Description:

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

Treatment:

Procedure: Topical strabismus surgery

Sub-Tenon's anesthesia

Active Comparator group

Description:

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

Treatment:

Procedure: Sub-Tenon's strabismus surgery