Botulinum Toxin Augmented Surgery vs Conventional Surgery in the Management of Large Angle Horizontal Deviations

NCT03266549 | Unknown DMC

• 1 other identifier: Botox Horizontal Strabismus
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Horizontal strabismus includes esotropia and exotropia where there is inward or outward deviation of visual axes of the eyes respectively. The most common initial treatment of horizontal strabismus is either bilateral rectus muscle recessions or unilateral recession resection surgery. For large angle deviations (\>50 prism diopters \[PD\]), surgery on 2 muscles alone may not be adequate with high reoperation rates. Approaches to these patients included large bilateral muscle recessions, supramaximal unilateral recession resection procedure, three or four horizontal muscle surgery, or botulinum toxin augmented surgery. Botulinum toxin augmentated strabismus surgery was reported in several studies. Owens et al.reported successful botulinum toxin augmentation of monocular recession-resection surgeries in 3 large-angle exotropia patients with successful results in two of the 3 patients. Khan reported 8 patients with \> 60 PD esotropia treated with botulinum-augmented surgery. Six of 8 had deviations of 10 PD or less following surgery. Özkan et al used botulinum augmentation in a group of older patients with large angle esotropia of different etiologies, with a success rate of 57%. Lueder et al evaluated the long-term outcomes in patients with infantile esotropia. The results were good, with a 74% success rate. Based on historical comparisons, this technique appears equally as effective as 3- or 4-muscle surgery and more effective than large bilateral medial rectus recessions alone. Ideally, a prospective randomized study should be performed to more definitively determine the effectiveness of intraoperative botulinum toxin augmentation compared to surgery alone.

Conditions

Large Angle Horizontal Strabismus

Keywords

botulinum toxin; horizontal strabismus

Outcome Measures

Primary Outcomes (1)

• success rate

  Outcomes will be considered successful if the patients had orthotropia ±10 PD

  Patients will be examined at 1 week after surgery

Secondary Outcomes (2)

• incidence of complications

  Patients will be examined at 1 week after surgery

• Ocular alignment

  12 months postoperative

Study Arms (2)

Botulinum toxin augmented surgery group

EXPERIMENTAL

unilateral recess-resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle.

Procedure: botulinum toxin augmented surgery

conventional surgery group

ACTIVE COMPARATOR

unilateral recess-resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia.The standard correction tables will be used as a guide for the amount of muscle recession and, or resection

Procedure: conventional surgery

Interventions

botulinum toxin augmented surgery PROCEDURE

unilateral recess-resect procedure, or bilateral rectus muscle recession plus intraoperative injection of 2.5 to 5 units of botulinum toxin A into the recessed muscle.

Botulinum toxin augmented surgery group

conventional surgery PROCEDURE

unilateral recess-resect procedure, bilateral rectus muscle recession, or 3 horizontal rectus muscle surgery according to the type of strabismus and the presence or absence of deep amblyopia. The standard correction tables will be used as a guide for the amount of muscle recession and, or resection.

conventional surgery group

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Large angle concomitant horizontal strabismus (\>50 prism diopters)

You may not qualify if:

• Other neurologic, or developmental disorders
• Vertical deviation
• Significant A or V patterns
• Paralytic or restrictive forms of strabismus
• History of eye surgery (strabismus or otherwise)

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Ophthalmology department, faculty of medicine, Assiut university

Asyut, 71526, Egypt

Location

Related Publications (9)

• Lueder GT, Galli M, Tychsen L, Yildirim C, Pegado V. Long-term results of botulinum toxin-augmented medial rectus recessions for large-angle infantile esotropia. Am J Ophthalmol. 2012 Mar;153(3):560-3. doi: 10.1016/j.ajo.2011.08.019. Epub 2011 Oct 13.

  PMID: 21996305 BACKGROUND

• Vroman DT, Hutchinson AK, Saunders RA, Wilson ME. Two-muscle surgery for congenital esotropia: rate of reoperation in patients with small versus large angles of deviation. J AAPOS. 2000 Oct;4(5):267-70. doi: 10.1067/mpa.2000.106960.

  PMID: 11040475 BACKGROUND

• Bayramlar H, Karadag R, Yildirim A, Ocal A, Sari U, Dag Y. Medium-term outcomes of three horizontal muscle surgery in large-angle infantile esotropia. J Pediatr Ophthalmol Strabismus. 2014 May-Jun;51(3):160-4. doi: 10.3928/01913913-20140318-02. Epub 2014 Mar 25.

  PMID: 24654800 BACKGROUND

• Minkoff OV, Donahue SP. Three-muscle surgery for infantile esotropia in children younger than age 2 years. J Pediatr Ophthalmol Strabismus. 2005 May-Jun;42(3):144-8; qiuz 174-5. doi: 10.3928/01913913-20050501-01.

  PMID: 15977866 BACKGROUND

• Khan AO. Two horizontal rectus eye muscle surgery combined with botulinum toxin for the treatment of very large angle esotropia. A pilot study. Binocul Vis Strabismus Q. 2005;20(1):15-20.

  PMID: 15828866 BACKGROUND

• Ozkan SB, Topaloglu A, Aydin S. The role of botulinum toxin A in augmentation of the effect of recession and/or resection surgery. J AAPOS. 2006 Apr;10(2):124-7. doi: 10.1016/j.jaapos.2005.11.011.

  PMID: 16678746 BACKGROUND

• McNeer KW, Tucker MG, Spencer RF. Botulinum toxin management of essential infantile esotropia in children. Arch Ophthalmol. 1997 Nov;115(11):1411-8. doi: 10.1001/archopht.1997.01100160581010.

  PMID: 9366672 BACKGROUND

• Owens PL, Strominger MB, Rubin PA, Veronneau-Troutman S. Large-angle exotropia corrected by intraoperative botulinum toxin A and monocular recession resection surgery. J AAPOS. 1998 Jun;2(3):144-6. doi: 10.1016/s1091-8531(98)90004-0.

  PMID: 10532749 BACKGROUND

• Minguini N, de Carvalho KM, Bosso FL, Hirata FE, Kara-Jose N. Surgery with intraoperative botulinum toxin-A injection for the treatment of large-angle horizontal strabismus: a pilot study. Clinics (Sao Paulo). 2012;67(3):279-82. doi: 10.6061/clinics/2012(03)13. No abstract available.

  PMID: 22473411 BACKGROUND

Study Officials

• sara Alattar

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sara Alattar, Msc

CONTACT

01004450144; alattarsara@yahoo.com

Sara Alattar, Msc

CONTACT

01004450144; saraalattar@aun.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer

Study Record Dates

• First Submitted: August 26, 2017
• First Posted: August 30, 2017
• Study Start: February 20, 2021
• Primary Completion: August 31, 2021
• Study Completion: November 30, 2021
• Last Updated: February 21, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)