| CTRI Number |
CTRI/2020/04/024666 [Registered on: 16/04/2020] Trial Registered Prospectively |
| Last Modified On: |
08/04/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Other |
|
Public Title of Study
|
Studying the effect of intramuscular injection of botulinum toxin in Duane retraction syndrome |
|
Scientific Title of Study
|
Evaluation of effect of botulinum toxin on strabismus associated with Duane retraction syndrome. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariani Avani Ajay |
| Designation |
Post graduate resident |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, Maharaja Ranjeet Singh Marg, 64 Khamba, New Delhi, Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9833727084 |
| Fax |
|
| Email |
avanihariani@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kamlesh |
| Designation |
Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, Maharaja Ranjeet Singh Marg, 64 Khamba, New Delhi, Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9811240575 |
| Fax |
|
| Email |
profkam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Kamlesh |
| Designation |
Professor |
| Affiliation |
Guru Nanak Eye Centre |
| Address |
Department of ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, Maharaja Ranjeet Singh Marg, 64 Khamba, New Delhi, Delhi 110002
New Delhi
DELHI
110002
India |
| Phone |
9811240575 |
| Fax |
|
| Email |
profkam@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, New Delhi 110002 |
|
|
Primary Sponsor
|
| Name |
Department of Ophthalmology Guru Nanak Eye Centre |
| Address |
Guru Nanak Eye Centre, Maulana Azad Medical College, Bahadur Shah Zafar Marg, New Delhi 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Hariani Avani Ajay |
Guru Nanak Eye Centre |
Department of ophthalmology, Guru Nanak Eye Centre, Maulana Azad Medical College, Maharaja Ranjeet Singh Marg, 64 Khamba, New Delhi 110002
New Delhi
DELHI |
9833727084
avanihariani@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H508||Other specified strabismus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intramuscular botulinum toxin injection |
After grasping muscle insertion, the globe abducted (for medial rectus) and adducted (for lateral rectus) using toothed forceps approximately Dose: 5 U (0.1 ml) of Botulinum toxin (50 units diluted with 1ml of distilled water)
Route of administration: using a 30G needle directly into the muscle belly without EMG guide through a trans-conjunctival route under anesthesia appropriate for age, under surgical microscope
Frequency: one single dose
Duration of follow up: 2 months |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
7.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with all types of Duane Retraction Syndrome
Patients with following complaints at presentation
-Ocular misalignment in primary gaze
-Abnormal head posture
-Retraction of globe/ narrowing of palpebral aperture
-Significant overshoot phenomenon
|
|
| ExclusionCriteria |
| Details |
Known neuromuscular disorder
Known systemic neurological disorder
History of previous squint surgery
Pattern strabismus (A, V, X , λ)
Nystagmus
History of previous BTX injection for strabismus
Hypersensitivity to BTX.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ocular alignment in primary gaze |
Day 1, 1 week, 1 month, 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Abnormal head posture
|
Day 1, 1 week, 1 month, 2 months |
| Globe Retraction |
Day 1, 1 week, 1 month, 2 months |
| Overshoot phenomenon |
Day 1, 1 week, 1 month, 2 months |
| Binocular status |
Day 1, 1 week, 1 month, 2 months |
| Complications |
Day 1, 1 week, 1 month, 2 months |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/04/2020 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Botulinum toxin (BTX) injection has been used in a wide spectrum of strabismus disorders, including congenital esotropia, acute paralytic strabismus, thyroid associated orbitopathy, and congenital nystagmus. However, studies assessing the clinical outcome of botulinum toxin injection in the patients with Duane syndrome are limited. Patients with DRS are often extremely symptomatic and demand further treatment. This study aims at assessing the effect of BTX in management of squint in DRS.
|