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.: PACTR201508001241218 Date of Registration: 17/08/2015
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title botulinum in childhood strabismus
Official scientific title Botulinum Neurotoxin as first line therapy in the management of Childhood esotropia
Brief summary describing the background and objectives of the trial Esotropia is the most common type of strabismus in childhood. While accommodative esotropia is the most common type in industrial countries, infantile esotropis is the commonest type seen in our population. Early treatment of infantile esotropia has been shown to be associated with a greater chance of developing depth perception. Surgery is the standard of treatment for infantile esotropia.In resource limited centers strabismus surgery is often relegated in preference to other more sight saving procedures. This results in a long delays in correcting strabismus in childhood. Botulinum neurotoxin injections have been used as an alternative therapy in the management of childhood esotropia.It is a quicker procedure with few complications. Many more patients can be treated in a given time when compared to surgery although repeat injections may be needed.In reported studies the success of surgery ranges from 60-80%, while the success of botulinum neurotoxin ranges from 42-60%. The primary objective of the study is to compare outcomes in patients with concomitant esotropia receiving Botulinum injections to those undergoing standard surgical care. Secondary objectives are to establish a. if the response to botulinum neurotoxin is influenced by the age at which the injection is first given.b. to establish if the baseline angle of strabismus will influence the response to the injection.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied childhood strabismus,Eye Diseases,Paediatrics,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Other
Anticipated trial start date 02/02/2015
Actual trial start date 06/02/2015
Anticipated date of last follow up 31/03/2017
Actual Last follow-up date
Anticipated target sample size (number of participants) 250
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
M140225 Human Research Ethics Comm (medical) University of the Witwatersrand
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 1:1 allocation stratified according to age Allocation by assistant not actively involved in the management trial Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group recession surgery to medial recti, both eyes once off N/A standard surgery 125 Active-Treatment of Control Group
Experimental Group Botulinum neurotoxin 5 units squints more or equal 40 diopters; 2.5units for less than 40 diopters Repeated if needed at each visit at 6 wks and 3mnths for max 3 injections Botulinum neurotoxin injected into both medial rectus muscles. Time for each injection under general anesthesia is 15 min 125
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Children between the ages of 6 months to 6 years with essential esotropia. Children with partially accommodative esotropia who require surgery to correct residual angle. Children diagnosed with acquired non accommodative esotropia. Children with concomitant esotropia secondary to neurodevelopmental disorders. Any concomitant esotropia corrected fully with spectacle correction. Significant associated vertical misalignment such as dissociative vertical deviation or inferior oblique overaction requiring surgery for these conditions. Strabismus secondary to ocular pathology. incomitant esotropia. Patients refusing to be randomised. 6 Month(s) 6 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
Yes Human research ethics comm of university of Witwatersrand
Ethics Committee Address
Street address City Postal code Country
1 York Road Parktown Johannesburg 2197 South Africa
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome degree of alignment 3 weeks. 6 weeks. 3 months. 6 months
Primary Outcome Adverse events 3 weeks. 6 weeks. 3 months. 6 months.
Primary Outcome cost effectiveness comparison 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
St John Eye Hospital Chris Hani Road Soweto - Johannesburg 2133 South Africa
FUNDING SOURCES
Name of source Street address City Postal code Country
Anglo American Chairmans Fund Fox Street Johannesburg 2000 South Africa
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Secondary Sponsor St John Foundation Westcliff road Johannesburg 2196 South Africa Charities/Societies/Foundation
COLLABORATORS
Name Street address City Postal code Country
Ismail Mayet St John eye hospital Soweto - Johannesburg 2133 South Africa
Sara Young St John eye hospital Soweto - Johannesburg 2133 South Africa
Hemant Kana St John eye hospital Soweto - Johannesburg 2133 South Africa
Mohammed Tikly Chris Hani Baragwanath hospital Soweto - Johannesburg 2133 South Africa
Susan Williams Johannesburg Hospital Johannesburg 2196 South Africa
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Ismail Mayet eyemay.im@gmail.com 027844105769 St John Eye Hospital Soweto
City Postal code Country Position/Affiliation
Johannesburg 2133 South Africa adjunct professor
Role Name Email Phone Street address
Public Enquiries Adelaide Molepane cockinos@afrisys.co.za 027119338783 St John Eye Hospital Soweto
City Postal code Country Position/Affiliation
Johannesburg 2133 South Africa assistant
Role Name Email Phone Street address
Scientific Enquiries Hemant Kana dockana@gmail.com 027119338783 St John Eye Hospital Soweto
City Postal code Country Position/Affiliation
Johannesburg 2133 South Africa senior specialist
REPORTING
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URL Results Available Results Summary Result Posting Date First Journal Publication Date
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Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information