Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201709002522352 Date of Approval: 17/08/2017
Trial Status: Registered in accordance with WHO and ICMJE standards
TRIAL DESCRIPTION
Public title Botulinum toxin augmented surgery vs conventional surgery in the management of large angle infantile esotropia
Official scientific title Botulinum toxin augmented surgery versus conventional surgery in the management of large angle infantile esotropia
Brief summary describing the background and objectives of the trial Infantile esotropia is defined as the onset of constant convergent squint in children less than 6 months of age. Infantile esotropia is mainly treated surgically using either bilateral medial rectus muscle recessions or unilateral medial rectus muscle recession and lateral rectus muscle resection with the main goal being to align the eyes so that single binocular vision may develop. For infants with very large angles of esotropia (>60 prism diopters [PD]), surgery on 2 muscles alone may not be adequate. Approaches to these patients have included large bilateral medial rectus muscle recessions, smaller bilateral medial rectus muscle recessions combined with resections of 1 or both lateral rectus muscles or botulinum toxin augmented bimedial recession. Botulinum toxin augmentation of medial rectus muscle recession was reported in three previous studies. Lueder et al evaluated the long-term outcomes in patients with infantile esotropia. The results were good, with a 74% success rate(8). 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 which of these approaches is best.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied infantile esotropia,Neonatal Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/09/2017
Actual trial start date
Anticipated date of last follow up 31/08/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 46
Actual target sample size (number of participants)
Recruitment status Not yet recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised randomisation table created by computer software program Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group botulinum toxin augmented bimedial recession bilateral 7 mm medial rectus muscle recessions, with augmentation with 1.25 units of botulinum toxin in 1 muscle for patients with deviations of 65 to 70 PD, and 2.5 units (either 1.25 units in both muscles or 2.5 units in 1 muscle) for patients with deviations greater than 70 PD 23
Control Group conventional surgery bilateral MR muscle recessions combined with unilateral or bilateral LR muscle resections (according to the standard correction tables) 23 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Large angle infantile esotropia (>60 prism diopters) Other neurologic, ocular, or developmental disorders Oblique muscle dysfunction Vertical deviation Significant A or V patterns Paralytic or restrictive forms of strabismus History of eye surgery (strabismus or otherwise) 6 Month(s) 10 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
No 01/09/2017 Assiut medical school ethical committee
Ethics Committee Address
Street address City Postal code Country
faculty of medicine, assiut university, 71515 Assiut Assiut +2 Egypt
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome success rate 1 week postoperative 1 month postoperative 3 months postoperative 6 months postoperative
Secondary Outcome degree of ocular alignment 1 week postoperative 1 month postoperative 3 months postoperative 6 months postoperative
Secondary Outcome incidence of complications 1 week postoperative 1 month postoperative 3 months postoperative 6 months postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Assiut university 71515 Assiut +2 Egypt
FUNDING SOURCES
Name of source Street address City Postal code Country
Assiut university 71515 Assiut +2 Egypt
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculty of medicine , Assiut university 71515 Assiut +2 Egypt University
COLLABORATORS
Name Street address City Postal code Country
Sara Alattar faculty of medicine, assiut university , 71515 Assiut +2 Egypt
Mohamed Anwar Sayed faculty of medicine, assiut university , 71515 Assiut +2 Egypt
Mohamed Saad Abdelrahman faculty of medicine, assiut university , 71515 Assiut +2 Egypt
Samir Yahia faculty of medicine, assiut university , 71515 Assiut +2 Egypt
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Samir Yahia samir.abouelail@med.au.edu.eg +201003304320 faculty of medicine, assiut university , 71515
City Postal code Country Position/Affiliation
Assiut +2 Egypt
Role Name Email Phone Street address
Public Enquiries Sara Alattar alattarsara@yahoo.com +201004450144 faculty of medicine , assiut university, 71515
City Postal code Country Position/Affiliation
Assiut +2 Egypt assiut university
Role Name Email Phone Street address
Scientific Enquiries Sara Alattar alattarsara@yahoo.com +201004450144 faculty of medicine , assiut university, 71515
City Postal code Country Position/Affiliation
Assiut +2 Egypt assiut university
REPORTING
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Result URL Hyperlinks
Changes to trial information