| CTRI Number |
CTRI/2025/09/095349 [Registered on: 24/09/2025] Trial Registered Prospectively |
| Last Modified On: |
22/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Computer based vision therapy ] |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effectiveness of Digital Computer Based Eye Exercises for Childhood Eye Coordination Problems |
|
Scientific Title of Study
|
Evaluating the Effectiveness of Computer Based Vision Therapy for Convergence Insufficiency in Paediatric Patients at a Tertiary Eye Care Hospital |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sivadharani S |
| Designation |
Primary DNB |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, sathy road, Sivanandapuram, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9994599800 |
| Fax |
|
| Email |
sivadharani496@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sivadharani S |
| Designation |
Primary DNB |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, sathy road, Sivanandapuram, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9994599800 |
| Fax |
|
| Email |
sivadharani496@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sivadharani S |
| Designation |
Primary DNB |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital, sathy road, Sivanandapuram, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9994599800 |
| Fax |
|
| Email |
sivadharani496@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital Coimbatore |
|
|
Primary Sponsor
|
| Name |
Sivadharani S |
| Address |
Sankara Eye Hospital, sathy road, Sivanandapuram, Coimbatore |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Sivadharani |
Sankara Eye Hospital |
Sathy road, Sivanandapuram, Coimbatore
Coimbatore
TAMIL NADU |
9994599800
sivadharani496@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H511||Convergence insufficiency and excess, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Computer based vision therapy |
Participants will undergo 5 sessions per week for 2 weeks of in office Computer based vision therapy for convergence insufficiency followed by 2 weeks of home based maintenance therapy |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
17.00 Year(s) |
| Gender |
Both |
| Details |
Child aged 8 to 17 years
Diagnosed with convergence insufficiency irrespective of refractive status of eye
Willingness to participate in computer based vision therapy sessions
BCVA of 6/9 or better in each eye |
|
| ExclusionCriteria |
| Details |
Presence of manifest strabismus or amblyopia
History of strabismus or refractive ocular surgeries
Neurological Disorders affecting vision like cerebral palsyand epilepsy
Children with attention deficit or other developmental delays preventing cooperation
Previous treatment for Convergence Insufficiency |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Changesin Convergence Insufficiency Symptom Survey CISS score, NPC,PFV from baseline, 2 weeks, 6 weeks and 12 weeks following computer-based vision therapy |
Changesin Convergence Insufficiency Symptom Survey CISS score, NPC,PFV from baseline, 2 weeks, 6 weeks and 12 weeks following computer-based vision therapy |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="52"
Sample Size from India="52"
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)
|
05/10/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
This is a single arm prospective interventional study designed to evaluate the effectiveness of computer based vision therapy in improving convergence insufficiency in paediatric patients Participants Diagnosed with convergence insufficiency will undergo structured vision therapy using Visuoprime software for 5 sessions per week for 2 weeks followed by 2 weeks of home based maintenance therapy Study aims to assess improvements in convergence function and also symptoms relief |