| CTRI Number |
CTRI/2025/10/096226 [Registered on: 21/10/2025] Trial Registered Prospectively |
| Last Modified On: |
21/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Prospective] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To find out the effective counselling method for accepting the strabismus surgery among the pediatric |
|
Scientific Title of Study
|
Comparing the Effectiveness of Different Counselling Methods for Strabismus Surgery in Paediatrics: A Study of Image-based, Animation-based, and Verbal Counselling |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
K Veena |
| Designation |
Chief Paediatric Ophthalmology & Strabismus Service, |
| Affiliation |
Aravind Eye Hospital |
| Address |
Paediatrics Department, Room No 12
Cuddalore main road, Thavalakuppam
Pondicherry
PONDICHERRY
605007
India |
| Phone |
09442891143 |
| Fax |
0413-2618848 |
| Email |
veena@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
K Veena |
| Designation |
Chief Paediatric Ophthalmology & Strabismus Service, |
| Affiliation |
Aravind Eye Hospital |
| Address |
Paediatric Department, Room No 12
Cuddalore main road, Thavalakuppam
Pondicherry
PONDICHERRY
605007
India |
| Phone |
09442891143 |
| Fax |
0413-2618848 |
| Email |
veena@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
K Veena |
| Designation |
Chief Paediatric Ophthalmology & Strabismus Service, |
| Affiliation |
Aravind Eye Hospital |
| Address |
A Block ground floor Room No 12
Cuddalore main road, Thavalakuppam
Pondicherry
PONDICHERRY
605007
India |
| Phone |
09442891143 |
| Fax |
0413-2618848 |
| Email |
veena@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital, Cuddaore main road, Thavalakuppam, Pondicherry 605007, India |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital |
| Address |
Cuddalore main road, Thavalakuppam, Pondicherry 605 007, India |
| 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 K Veena |
Aravind Eye Hospital |
A Block, Room No 12, Ground Floor, Paediatric Ophthalmology
Aravind Eye Hospital, Cuddalore main road, Thavalakuppam, Pondicherry
Pondicherry
PONDICHERRY |
09442891143
veena@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H500||Esotropia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
16.00 Year(s) |
| Gender |
Both |
| Details |
Patients aged 5 to 16 years who are advised for strabismus surgery at Aravind Eye Hospital, Pondicherry counselled along with their parents. |
|
| ExclusionCriteria |
| Details |
1. Patients who have already received any ocular surgery.
2. Patients with siblings who have undergone squint surgery.
3. Patients who are specially challenged or systemic illnesses that interfere with the benefits of squint surgery.
4. Patients who are actively advised to undergo other ocular procedures.
5. Patients who are greater than16 years of age.
6. Patients who are not willing to enroll in the study.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The image-based counselling or animation-based counselling will increase strabismus surgery admit rates in comparison to the verbal counselling. |
3 months |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
03/11/2025 |
| 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="1"
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
|
Hypothesis
We
hypothesize that showing pre-op and post-op photos of past patients who have
undergone strabismus surgery at Aravind Eye Care, Pondicherry, will increase
the strabismus surgery admit rate. Parents will be more inclined to agree to
the surgery after seeing historical success of the surgery.
We
further hypothesize that a technical animation on how the procedure is
performed extraocular and how it can restore binocular vision will increase the
strabismus surgery admit rate. Parents will better understand the surgery and
its benefits.
Aim
To evaluate the difference in
effectiveness of using a technical animation, pre-op/post-op images, and verbal
communication in counselling for paediatric patients advised for strabismus
surgery.
Objectives
Primary:
Evaluate the effectiveness of each counselling method through the respective
acceptance rates to surgery.
Secondary:
Evaluate the effectiveness of each counselling method through how well it
conveys understanding and benefits of the surgery to patients’ parents. This
can be seen in the results of the questionnaire’s ‘Surgery Understanding’
section. |