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CTRI Number  CTRI/2023/04/051497 [Registered on: 11/04/2023] Trial Registered Prospectively
Last Modified On: 11/04/2023
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Using a special camera to examine eye muscles after surgery to fix crossed eyes - A study 
Scientific Title of Study   Imaging of Extra-Ocular Muscles Post Strabismus-Surgery Employing AS-OCT – A Prospective, Observational Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Hari Bhadari Anand 
Designation  Primary DNB Resident 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room No.12, Paediatric Ophthalmology and Strabismus Services, Aravind Eye Hospital, Thavalakuppam, Cudallore Main Road, Pondicherry, 605007

Pondicherry
PONDICHERRY
605007
India 
Phone  8921347960  
Fax    
Email  haribhadari.anand@aravind.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Marie Fredrick Mouttapa 
Designation  Consultant 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room No.12, Paediatric Ophthalmology and Strabismus Services, Aravind Eye Hospital, Thavalakuppam, Cudallore Main Road, Pondicherry, 605007

Pondicherry
PONDICHERRY
605007
India 
Phone  9894290702  
Fax    
Email  dr.fredrick@aravind.org  
 
Details of Contact Person
Public Query  
Name  Dr Hari Bhadari Anand 
Designation  Primary DNB Resident 
Affiliation  Aravind Eye Hospital, Pondicherry 
Address  Room No.12, Paediatric Ophthalmology and Strabismus Services, Aravind Eye Hospital, Thavalakuppam, Cudallore Main Road, Pondicherry, 605007

Pondicherry
PONDICHERRY
605007
India 
Phone  8921347960  
Fax    
Email  haribhadari.anand@aravind.org  
 
Source of Monetary or Material Support  
Aravind Eye Hospital, Thavalakuppam, Cudallore Main Road, Pondicherry, 605007 
 
Primary Sponsor  
Name  Dr Hari Bhadari Anand 
Address  Room No.12, Paediatric Ophthalmology and Strabismus Services, Aravind Eye Hospital, Thavalakuppam, Cudallore Main Road, Pondicherry, 605007 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
Nil  Nil 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Hari Bhadari Anand  Aravind Eye Hospital, Pondicherry  Room No.12, Paediatric Ophthalmology and Strabismus Services, Aravind Eye Hospital, Thavalakuppam, Cudallore Main Road, Pondicherry, 605007
Pondicherry
PONDICHERRY 		 8921347960

haribhadari.anand@aravind.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H49-H52||Disorders of ocular muscles, binocular movement, accommodation and refraction,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  1.00 Month(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All patients presenting for follow-up post strabismus surgery involving the horizontal rectus muscles (Resection, Recession) 
 
ExclusionCriteria 
Details  Disorders that affect the ability to sit at the machine properly for the investigative modality (AS-OCT) 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To analyse the percentage of EOM we are able to locate at the new insertion point post squint-correction, via AS-OCT  One year and six months 
 
Secondary Outcome  
Outcome  TimePoints 
• To study which paediatric age group will be co-operative for this modality of scanning.
• To define field-limits for detection of EOM.
• To explore the minimum post-operative period when the muscle can be visualised clearly.
• To study changes in insertion-site of the operated EOM post-operatively.
• To correlate between axial length and the field of limits of detection.
 		 One year and six months 
 
Target Sample Size   Total Sample Size="95"
Sample Size from India="95" 
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)   18/04/2023 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Yet Published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Primary Objectives:

·       To analyse the percentage of EOM we are able to locate at the new insertion point post squint-correction, via AS-OCT

.

 

Secondary Objectives:

To study which paediatric age group will be co-operative for this modality of scanning.

·       To define field-limits for detection of EOM.

·       To explore the minimum post-operative period when the muscle can be visualised clearly.

·       To study changes in insertion-site of the operated EOM post-operatively.

·       To correlate between axial length and the field of limits of detection.

Expected Outcome:  We expect to find what muscles and upto which extent of resection can be visualised under AS-OCT post-operatively, to find what age group of children will be co-operative to testing via AS-OCT & to define the post-op timeframe from which AS-OCT might be a viable investigation to clearly distinguish the insertion of the EOM.






 
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