Evaluation of The Techniques in Correcting Large-Angle Exotropia

NCT06084442 | Unknown

• 1 other identifier: Large-Angle Exotropia
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is to evaluate the techniques of combined lateral rectus muscle recession with hang back and combined lateral rectus muscle recession with z-tenotomy in correcting large-angle exotropia.

Conditions

Exotropia; Evaluation of Surgical Techniques in Correcting Exotropia

Outcome Measures

Primary Outcomes (1)

• sucessful alignment

  Successful motor alignment will be defined as orthotropia or ≤ 10 Δ Exotropia or Esotropia at 6 m distance with spectacle correction worn at 6 months. Successful sensory alignment will be by achievement of fusion and moderate or good stereoacuity postoperatively.

  Follow up period of 6 month from the time of initial surgery. All patients will be examined at one week, one month, 3 month and 6 months.

Study Arms (2)

combined lateral rectus muscle recession 7mm and hang back technique.

ACTIVE COMPARATOR

The technique of combined LR recession 7mm and hang back technique: A. The muscle is exposed in the usual manner and locking suture is passed through full thickness of the LR muscle using nonabsorbable ethibond suture. B. The muscle is cut from its insertion site. C. Marking the sclera for the rectus muscle recession. a Measurement from the limbus, or b measurement from the original insertion site. D. Passage of the needles in the sclera using the "crossed swords" Technique E. The muscle has been pulled up to its new insertion point and the sutures have been tied and cut and the remainder of the procedure is identical to the standard hang-back method. The

Procedure: Evaluation of The Techniques of Lateral Rectus Muscle Combined Recession with Hang Back and Combined Recession with Z-Tenotomy in Correcting Large-Angle Exotropia

combined lateral rectus muscle recession 7mm and Z- tenotomy technique.

ACTIVE COMPARATOR

The technique of lateral rectus muscle Z-tenotomy: A. The muscle is exposed in the usual manner and two hemostats are each placed 80% of the way across the muscle (or tendon) from opposite borders. The hemostats are placed 3 or 4 mm apart. B. The posterior hemostat is removed, and scissors are used to cut across the muscle in the crushed area. By cutting the muscle in the crushed area, bleeding is kept to a minimum. C. The hemostat nearer the insertion is removed, and the muscle is cut along the crushed area using small snips with scissors. D. lengthening of the muscle will occur. Any bleeding is controlled with pressure. E. After the distal myotomy has been performed, in a very tight muscle, a No. 15 Bard Parker blade can be used to divide the tendon fibers, cutting against the muscle hook. This can be accomplished with a scraping motion with the knife blade at nearly right angles to avoid scleral perforation.

Procedure: Evaluation of The Techniques of Lateral Rectus Muscle Combined Recession with Hang Back and Combined Recession with Z-Tenotomy in Correcting Large-Angle Exotropia

Interventions

Evaluation of The Techniques of Lateral Rectus Muscle Combined Recession with Hang Back and Combined Recession with Z-Tenotomy in Correcting Large-Angle Exotropia PROCEDURE

Patients will be divided into 2 groups: * Group (A): Patients will undergo combined LR recession 7mm and hang back technique. * Group (B): Patients will undergo combined LR recession 7mm and Z-tenotomy technique.

combined lateral rectus muscle recession 7mm and Z- tenotomy technique.; combined lateral rectus muscle recession 7mm and hang back technique.

Eligibility Criteria

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

You may qualify if:

• Patients suffering from large angle exotropia; defined, in this study, as an angle of deviation ≥ 40 prism diopters (PD).

You may not qualify if:

• Patients suffering from exotropia with angle \< 40 prism diopters (PD).
• Patient with paralytic strabismus.
• Patient with restrictive strabismus.
• Patient with combined vertical and horizontal deviation.
• Patients with previous strabismus surgery.
• Patients who had previously been administered botulinum toxin A.
• Patient refusal.

Sponsors & Collaborators

• Tanta University: lead

Related Publications (6)

• Livir-Rallatos G, Gunton KB, Calhoun JH. Surgical results in large-angle exotropia. J AAPOS. 2002 Apr;6(2):77-80. doi: 10.1067/mpa.2002.122059.

  PMID: 11997802 BACKGROUND

• Chen JH, Morrison DG, Donahue SP. Three and Four Horizontal Muscle Surgery for Large Angle Exotropia. J Pediatr Ophthalmol Strabismus. 2015 Sep-Oct;52(5):305-10. doi: 10.3928/01913913-20150609-02. Epub 2015 Jun 15.

  PMID: 26098544 BACKGROUND

• Chung AK, Rehman SU, Bradbury JA. Comparison of modified anchored "hang-back technique (HBT)" with conventional HBT in bimedial rectus recession. J AAPOS. 2005 Jun;9(3):234-9. doi: 10.1016/j.jaapos.2005.02.011.

  PMID: 15956942 BACKGROUND

• Betts C, Olitsky S. Corneal astigmatic effects of conventional recession vs suspension recession ("hang-back") strabismus surgery: a pilot study. Binocul Vis Strabismus Q. 2006;21(4):211-3.

  PMID: 17069557 BACKGROUND

• Orlin A, Mills M, Ying GS, Liu C. A comparison of hang-back with conventional recession surgery for exotropia. J AAPOS. 2007 Dec;11(6):597-600. doi: 10.1016/j.jaapos.2007.06.001. Epub 2007 Oct 24.

  PMID: 17920319 BACKGROUND

• Shin A, Yoo L, Demer JL. Biomechanics of superior oblique Z-tenotomy. J AAPOS. 2013 Dec;17(6):612-7. doi: 10.1016/j.jaapos.2013.09.004.

  PMID: 24321425 BACKGROUND

MeSH Terms

Conditions

Exotropia

Condition Hierarchy (Ancestors)

Strabismus; Ocular Motility Disorders; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Study Officials

• El-Sayed Samir Arafa, MD

  Tanta University

  STUDY DIRECTOR

• Amr Mahmoud Awara, MD

  Tanta University

  STUDY DIRECTOR

• Heba Mohamed Shafik, MD

  Tanta University

  STUDY DIRECTOR

Central Study Contacts

Basma Gamal Mohamed Ahmed Sayed Ahmed, Msc

CONTACT

+20 1017954454; basmagamal9090@yahoo.com

Ahmed Lotfi Ali, MD

CONTACT

+20 1223407373; ahmedlotfi@hotmail.com

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

Model Details: Patients will be divided into 2 groups: * Group (A): Patients will undergo combined LR recession 7mm and hang back technique. * Group (B): Patients will undergo combined LR recession 7mm and Z-tenotomy technique.

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: October 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: April 1, 2024
• Last Updated: October 16, 2023

Record last verified: 2023-10