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Large Angle Horizontal StrabismusNCT03266549

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

A study testing botulinum toxin augmented surgery and conventional surgery in people with Large Angle Horizontal Strabismus, run by Assiut University at 1 site in Egypt.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 6 months and older
Conditions the study is for
Large Angle Horizontal Strabismus
What is being tested?
botulinum toxin augmented surgery and conventional surgery
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteEgypt
Study dates
20 Feb 2021to 30 Nov 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Ophthalmology department, faculty of medicine, Assiut university

    Asyut, 71526

    Sara Alattar, Msc, +201004450144, alattarsara@yahoo.com

    Mohamed Sayed Saad, PhD, +201001825024, mohsayedsaad@aun.edu.eg

Other trials in Egypt

About this study

Official title: Botulinum Toxin Augmented Surgery Versus Conventional Surgery in the Management of Large Angle Concomitant Horizontal Deviations

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.

Read the detailed description

Strabismus is defined as inability of the two eyes to align their visual axes to a common object of regard. Horizontal strabismus may be in the form of esotropia or exotropia depending on whether the visual axes and the eyes are converging or diverging respectively.

There are multiple surgical techniques used to treat horizontal strabismus with the main goal being to align the visual axes so that binocular vision may develop. The most common initial treatment 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 to correct the strabismus with high reoperation rates. Approaches to these patients have included large bilateral muscle recessions, supramaximal unilateral recession resection procedure, three or four horizontal muscle surgery, or botulinum toxin augmented surgery.

Botulinum toxin exerts its effect by interfering with release of acetylcholine at the neuromuscular junction, thus inhibiting muscle contraction. Although the pharmacologic effect of botulinum toxin is temporary, permanent results in patients with strabismus may occur. These effects include a change in the length-tension curves of the muscles and permanent changes in sarcomere density and myosin heavy chain composition.

Botulinum toxin alone has been advocated by McNeer and associates as a primary treatment for infantile esotropia in children with smaller angles of deviation. The advantage of this approach is that incisional surgery is not required. However, it was found that botulinum alone was less effective in establishing binocularity when compared to standard surgery. This is likely because multiple injections are often needed, which prolongs the duration of misalignment. On the other hand, the concomitant use of botulinum toxin and surgery allowed for rapid establishment of alignment. Other advantages of botulinum augmentation are that only 2 muscles are operated upon, thus decreasing anesthesia duration and the risk of surgical complications, and the lateral rectus muscles are preserved for additional surgery, if needed.

Botulinum toxin augmentation of strabismus surgery was reported in several previous studies. Owens et al. reported the successful intraoperative use of botulinum toxin to augment monocular recession-resection surgeries in three large-angle exotropia patients. Two of these patients had orthotropia ±10 PD at their final examinations, while the third patient demonstrated a stable 18 PD exotropia which was cosmetically satisfactory. Khan reported 8 patients with > 60 PD esotropia treated with botulinum-augmented horizontal muscle surgery. Six of 8 had deviations of 10 PD or less following surgery, with an average follow-up of 9 months. Özkan et al. used botulinum augmentation in a group of older patients (age range 5-50 years) with large-angle esotropia of different etiologies, with a success rate of 57% and an average follow-up of 14 months. Minguini et al. compared the results of surgery alone versus surgery plus treatment with botulinum toxin for treatment of 23 patient with large angle strabismus. Lueder et al. evaluated the long-term outcomes in patients with infantile esotropia who had been followed for more than 2 years after treatment. The results were good, with a 74% success rate. This study demonstrated that this procedure is an effective treatment for infants with large-angle infantile esotropia, with stable results over time2. Based on historical comparisons, it 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 the addition of intraoperative botulinum toxin compared to surgery alone.

Being tested
botulinum toxin augmented surgery, conventional surgery
Keywords
botulinum toxin, horizontal strabismus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • botulinum toxin augmented surgeryProcedure or surgery

    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.

  • conventional surgeryProcedure or surgery

    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.

Study groups in NCT03266549
Study groupRoleWhat they receive
Botulinum toxin augmented surgery groupExperimentalunilateral 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.
Receives: Procedure: botulinum toxin augmented surgery
conventional surgery groupActive comparatorunilateral 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
Receives: Procedure: conventional surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. success rate

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

    Measured: Patients will be examined at 1 week after surgery

Secondary outcomes (2)
  1. incidence of complications

    ptosis vertical deviation under-correction (residual esotropia) overcorrection (consecutive exotropia)

    Measured: Patients will be examined at 1 week after surgery

  2. Ocular alignment

    Orthotropia or angle of deviation if present

    Measured: 12 months postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2017
  2. Study start20 Feb 2021 (estimated)
  3. Primary completion31 Aug 2021 (estimated)
  4. Study completion30 Nov 2021 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03266549
Sponsor's protocol ID
Botox Horizontal Strabismus
Status last verified
Feb 2021
First submitted
26 Aug 2017
Last updated
21 Feb 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 21996305
  • 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.

    PubMed 11040475
  • 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.

    PubMed 24654800
  • 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.

    PubMed 15977866
  • 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.

    PubMed 15828866
  • 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.

    PubMed 16678746
  • 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.

    PubMed 9366672
  • 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.

    PubMed 10532749
  • 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.

    PubMed 22473411

Questions about this trial

What is this clinical trial studying?

A study testing botulinum toxin augmented surgery and conventional surgery in people with Large Angle Horizontal Strabismus, run by Assiut University at 1 site in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Sara Alattar, Msc (01004450144 ext. +2, alattarsara@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

success rate (time frame: Patients will be examined at 1 week after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03266549, which also lists 9 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2021.

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