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CTRI Number  CTRI/2024/01/061486 [Registered on: 15/01/2024] Trial Registered Prospectively
Last Modified On: 28/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Treatment Modalities ]  
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Comparison of Vision therapy and Routine treatment methods in patients with inconstant squint(outward deviation). 
Scientific Title of Study   Comparison between Vision Therapy and Conventional Therapy in Intermittent Exotropia. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vaishnavi Shyam Mahajan 
Designation  Primary DNB Resident 
Affiliation  Sankara Eye Hospital,Shimoga 
Address  Room no. 23, Department of Pediatric Ophthalmology, Sankara Eye Hospital, Harakere, Thirthahalli road, Shimoga

Shimoga
KARNATAKA
577202
India 
Phone  9403745450  
Fax    
Email  mahajanvaishnavi43@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kavitha V 
Designation  Senior Consultant, Pediatric Ophthalmology 
Affiliation  Sankara Eye Hospital, Shimoga 
Address  Room no. 23, Department of Pediatric Ophthalmology, Sankara Eye Hospital, Harakere, Thirthahalli road, Shimoga

Shimoga
KARNATAKA
577202
India 
Phone  9663329877  
Fax    
Email  kavithachalam@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Kavitha V 
Designation  Senior Consultant, Pediatric Ophthalmology 
Affiliation  Sankara Eye Hospital, Shimoga 
Address  Room no. 23, Department of Pediatric Ophthalmology, Sankara Eye Hospital, Harakere, Thirthahalli road, Shimoga

Shimoga
KARNATAKA
577202
India 
Phone  9663329877  
Fax    
Email  kavithachalam@yahoo.com  
 
Source of Monetary or Material Support  
Room no. 23, Department of Pediatric Ophthalmology, Sankara Eye Hospital, Harakere, Thirthahalli road, Shimoga 
 
Primary Sponsor  
Name  Sankara Eye Hospital, Shimoga 
Address  Harakere, Thirthahalli road, Shimoga 
Type of Sponsor  Research institution and hospital 
 
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 Vaishnavi Shyam Mahajan  Sankara Eye Hospital, Shimoga  Room no. 23, Department of Pediatric Ophthalmology, Sankara Eye Hospital, Harakere, Thirthahalli road, Shimoga
Shimoga
KARNATAKA 		 9403745450

mahajanvaishnavi43@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee- Sankara Eye Hospital, Shimoga  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H501||Exotropia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Home Based Exercises  At first Visit, post complete evaluation patient will be started on Home Based Exercises- Brock String and Hart Chart for 30 minutes a day for 24 hours 
Comparator Agent  Patching  At first visit, post complete evaluation patient will be started on home based patching of the non- deviating eye for 1 hour per day for 24 hours. 
Intervention  Vision Therapy  At first visit, post complete evaluation, patient will be started on in office vision therapy for 1 hour per day for 3 days a week for 24 hours. 
 
Inclusion Criteria  
Age From  5.00 Year(s)
Age To  18.00 Year(s)
Gender  Both 
Details  1 Vision better than or equal to 6 by 12 in the worse eye in group Vision therapy and Patching and vision 6 by 6 in both eyes in group Home based exercises.
2 All types of newly diagnosed Intermittent Exotropia.
4 Intermittent Exotropia with or without asthenopic symptoms.
5 Intermittent Exotropia with or without Refractive error.
 
 
ExclusionCriteria 
Details  1 Constant, Sensory, Incomitant, and Consecutive exotropia are excluded.
2 Exophoria more than 45 PD.
3 Intermittent Exotropia with vertical deviation.
4 Patient with any past history of treatment related to Vision and Strabismus
5 Patient who will opt out of treatment in between and those lost to follow up will be excluded.
6 Not compliant for evaluation or treatment.
7 Patient with systemic disorders- Developmental delay, CVS,CNS, RS, Endocrinology problems or associated ocular abnormalities except Refractive error with or without Amblyopia and Intermittent Exotropia.
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Evaluation of Fusion, Stereopsis and Angle of deviation in patients with Intermittent Exotropia.   At presentation(baseline) and after completion of 24 hours of therapy 
 
Secondary Outcome  
Outcome  TimePoints 
Best corrected Visual acuity in groups Vision Therapy and Patching.  At presentation(baseline) and after completion of 24 hours of therapy 
 
Target Sample Size   Total Sample Size="75"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= "75"
Final Enrollment numbers achieved (India)="75" 
Phase of Trial   N/A 
Date of First Enrollment (India)   18/01/2024 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary
Modification(s)  		 Intermittent Exotropia is defined as the occasional outward deviation of one eye or it can alternate between the eyes. Frequency, duration and control of deviation can vary from individual to individual.
It can occur due to defect in Innervation, mechanical factors, fusion faculty, AC/A ratio, and presence of refractive errors and hemiretinal suppression.
Observation and Patching has long been the mainstay of treatment. 
There are various studies available comparing patching and observation, comparing patching and Exercises but a very few are available comparing Vision therapy, Patching and Home based exercises in the age group of 5 to 18 years.
In this study we will be analysing and comparing the effect of Vision therapy and Conventional therapy (Patching and Home based exercises: Brock string and Hart chart) on Fusion, Stereopsis, Angle of deviation and Visual acuity and will compare the same among all three groups.
 
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