Comparison of Two Treatments for Strabismus Correction: Botulinum Toxin A Associated to Surgery and Surgery Alone

University of Campinas, Brazil

Status and phase: Completed; Phase 4

Conditions: Exotropia; Esotropia

Treatments: Drug: Botulinum Toxin Type A; Drug: saline solution

Study type: Interventional

Funder types: Other

Identifiers

NCT01460355

Unicamp-CEP- 427/2006

Details and patient eligibility

About

Two different treatments were given to large angle horizontal strabismus (eso and exotropia) adult patients who agree to participate of the study. Inform consents were required for participants. Group 1 (12 patients) received conventional recess-resect surgery plus intraoperative injection of botulinum toxin A (5U). Group 2 (11 patients) received only conventional recess-resect surgery. The patients were randomly located in one of the groups. The angles of horizontal deviation were compared between the groups before and six months after treatment.

Full description

Patients underwent recess/resection surgery on the non-fixating eye using conventional technique under local anesthesia. The extent of surgery was determined based on our usual amounts. Before re-attaching the recessed muscle to the sclera, 5 units of botulinum toxin in 0.1 ml of hyaline solution were, or 0.1 ml of hyaline solution alone were was injected into the posterior muscle belly by the surgeon who was unaware of the contents of each syringe.

Enrollment: 23 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adults with large angle horizontal strabismus

Exclusion criteria

• oblique muscle disfunction
• previous strabismus surgery
• dissociated vertical deviation
• paretic or restrictive deviation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

23 participants in 2 patient groups, including a placebo group

Botulinum toxin plus surgery

Active Comparator group

Description:

Intraoperative injection of 5U (0.1 ml) of Botulinum Toxin will be given to the recessed muscle during surgery

Treatment:

Drug: Botulinum Toxin Type A

Saline solution plus surgery

Placebo Comparator group

Description:

Saline solution (0,1 ml)will be given to the recessed muscle during surgery procedure

Treatment:

Drug: saline solution