| CTRI Number |
CTRI/2025/09/094254 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
03/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Non surgical orthoptic vision therapy] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Change in the squint with non-surgical treatment methods in intermittent exotropia, in children below 8 years of age |
|
Scientific Title of Study
|
Effectiveness of non-surgical intervention in Intermittent exotropia in children below 8 years of age |
| 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 Manasi Lad |
| Designation |
Principal Investigator |
| Affiliation |
Sankara Eye Hospital, Bengaluru |
| Address |
Varthur Main Rd, Kundalahalli Gate, Bengaluru, Karnataka
Bangalore
KARNATAKA
560037
India |
| Phone |
9769586002 |
| Fax |
|
| Email |
dr.manasilad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sowmya R |
| Designation |
Guide |
| Affiliation |
Sankara Eye Hospital, Bengaluru |
| Address |
Varthur Main Rd, Kundalahalli Gate, Bengaluru, Karnataka
Bangalore
KARNATAKA
560037
India |
| Phone |
9900087113 |
| Fax |
|
| Email |
sowmya@sankaraeye.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manasi Lad |
| Designation |
Principal Investigator |
| Affiliation |
Sankara Eye Hospital, Bengaluru |
| Address |
Varthur Main Rd, Kundalahalli Gate, Bengaluru, Karnataka
Bangalore
KARNATAKA
560037
India |
| Phone |
9769586002 |
| Fax |
|
| Email |
dr.manasilad@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital
Varthur Main Road, Kundalahalli Gate, Bengaluru 560037 |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital, Bengaluru |
| Address |
Varthur Main Road, Kundalahalli Gate, Bengaluru 560037 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr Manasi Lad |
Sankara Eye Hospital |
Room no.3, Department of Paediatric Ophthalmology, Squint, and Neuro-ophthalmology, Sankara Eye Hospital, Varthur Main Road, Kundalahalli Gate, Bengaluru 560037
Bangalore
KARNATAKA |
9769586002
dr.manasilad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H503||Intermittent heterotropia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Alternate Intermittent Patching, Computer based Binocular Vision Therapy, or combination of both |
Alternate intermittent patching of eye with orthoptic eye patch, 2 hours/day, every day of the week, alternate eye being patched every day.
Computer based Binocular Vision Therapy with VisuoPrime software, 30 mins session, 5 days/week. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
1.00 Day(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
Children below 8 years of age presenting with Intermittent Exotropia.
Children having intermittent exotropia for distance, and intermittent exotropia or exophoria for near.
No previous intervention for intermittent exotropia, except refractive correction. |
|
| ExclusionCriteria |
| Details |
Children with constant exotropia for distance or near.
Exotropia associated with syndromes or neurological disorders.
Prior ocular surgery or non-surgical intervention for intermittent exotropia. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Improvement/change in the parameters of intermittent exotropia in children below 8 years of age:
-Improvement in the Newcastle control score on follow up at 3 months, compared to the baseline measurement.
-Improvement in the angle of deviation on follow up at 3 months, compared to the baseline measurement. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| An interview-based improvement in the methods of non-surgical intervention to increase compliance and ease of delivering the treatment. |
1 year |
| Better short-term improvement in the angle of deviation and Newcastle score in intermittent exotropia. |
1 year |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2025 |
| Date of Study Completion (India) |
23/07/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title: Effectiveness of Non-Surgical Intervention in Intermittent Exotropia in Children Below 8 Years of Age
Intermittent exotropia (IXT) is one of the most common childhood strabismus disorders, characterized by intermittent outward deviation of one eye. Its progression varies widely, and both surgical and non-surgical interventions are employed, though there is limited consensus on optimal management in young children.
This study aims to evaluate the effectiveness of non-surgical interventions, specifically alternate intermittent occlusion (patching) and binocular vision therapy (BVT)—in improving ocular alignment, deviation control, and binocular vision in children under 8 years of age with IXT.
A prospective cohort study will be conducted from August 2025 to July 2026, enrolling 50 children diagnosed with IXT. Effectiveness will primarily be assessed using the Newcastle Control Score (NCS), along with measures of deviation angle, stereopsis, and caregiver perceptions through qualitative interviews.
The primary objective is to determine the change in NCS following intervention, while secondary objectives include evaluating caregiver perception, as well as the influence of age at onset and treatment on outcomes.
Expected results include improvement in control scores, angle of deviation, and compliance with non-surgical therapy. By integrating both clinical outcomes and caregiver perspectives, this study addresses current gaps in evidence and may help guide standardized non-surgical management protocols for IXT in younger children, potentially reducing the need for early surgical intervention. |