| CTRI Number |
CTRI/2025/09/095005 [Registered on: 17/09/2025] Trial Registered Prospectively |
| Last Modified On: |
17/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
This study will check for any changes in the eye after squint surgery in people aged 12 to 40 years. It aims to ensure the surgery is safe and does not affect the eye’s strength or vision in the long run.” |
|
Scientific Title of Study
|
Analysis of prevalence of corneal biomechanical changes post squint study in age group of 12-40 years |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dhanshree Rathod |
| Designation |
Secondary Dnb Trainee |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Main Road,
Vaikuntam layout,Laxminarayana Pura
Kundalahalli,Munnekollal
Bangalore
Bangalore KARNATAKA 560037 India |
| Phone |
8623952852 |
| Fax |
|
| Email |
dhanashree661@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Anand Balasubraminiam |
| Designation |
Cornea Consultant |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Main Road,
Vaikuntam layout,Laxminarayana Pura
Kundalahalli,Munnekollal
Bangalore
Bangalore KARNATAKA 560037 India |
| Phone |
9480587037 |
| Fax |
|
| Email |
moksha_abs2yahoo.co.in |
|
Details of Contact Person Public Query
|
| Name |
Dhanshree Rathod |
| Designation |
Secondary Dnb Trainee |
| Affiliation |
Sankara Eye Hospital |
| Address |
Sankara Eye Hospital
Varthur Main Road,
Vaikuntam layout,Laxminarayana Pura
Kundalahalli,Munnekollal
Bangalore
Bangalore KARNATAKA 560037 India |
| Phone |
8623952852 |
| Fax |
|
| Email |
dhanashree661@gmail.com |
|
|
Source of Monetary or Material Support
|
| Paediatric Department, Sankara Eye Hospital |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital |
| Address |
Paediatric Department, First Floor,Sankara Eye Hospital Varthur Main Road,Kundalahalli Gate,Bangalore |
| 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 |
| Dhanshree Rathod |
Department of Paediatric Ophthalmology ,Squint and Neuro-ophthalmology |
Room No 3, First floor, Sankara Eye Hospital
Varthur Main Road,Kundalahalli Gate,Bangalore-560037 Bangalore KARNATAKA |
8623952852
dhanashree661@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: H509||Unspecified strabismus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age group of 12-40 years posted for squint surgery. |
|
| ExclusionCriteria |
| Details |
Patients or parents not willing.
Any neurological abnormalities like cerebral palsy or mental retardation.
Any Prior ocular surgeries.
Transposition procedures done in the eye.
Restrictive strabismus. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Changes in corneal biomechanics using Corvis ST parameters:
CBI (Corvis biochemical Index)
TBI (Tomographic Biomechanical Index)
Transient corvis changes expected to normalize within 3 months of surgery |
Baseline preoperative, Postoperative 1 month and 3 months. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Influence of procedure type (recession, resection, or combined) on the magnitude of corneal biomechanical changes.
Assessment of the biomechanical changes in :
-Single vs multiple muscles operated in the eyes
-Limbal vs forniceal incision in the eye. |
Baseline preoperative, Postoperative 1 month and 3 months. |
|
|
Target Sample Size
|
Total Sample Size="42" Sample Size from India="42"
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)
|
29/09/2025 |
| 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
|
Title : Analysis of prevalence of corneal biochemical changes in post squint surgeries in patients with age group of 12-40 years.
Squint, also called crossed eyes, is a condition where the two eyes do not point in the same direction. This can affect a person’s appearance, confidence, and sometimes even their ability to see clearly with both eyes together. Surgery to correct squint is commonly done in both children and adults to improve eye alignment, vision, and quality of life. The front part of the eye, called the cornea, is like the clear window through which we see. It not only lets light into the eye but also has to stay strong and maintain its shape for clear vision. Now we have advanced tools like the Corvis ST, which use a gentle puff of air and a special camera to measure how flexible or strong the cornea is. These measurements can tell us if surgery affects the eye’s structure and whether those effects are temporary or long-lasting.
Study Purpose: This is a prospective cohort study will be conducted from August 2025 to July 2026,enrolling 42 patients with squint . This study will check if squint surgery causes any changes in the strength or flexibility of the eye in people aged 12 to 40 years. We will use the Corvis ST machine to measure these changes before surgery, and again at 1 month and 3 months after surgery. We will record information about each patient and measure the eye’s strength before surgery. Perform squint surgery using standard procedures. Repeat the eye strength test at 1 month and 3 months after surgery. Compare results based on the type of surgery, number of muscles operated, and type of incision used.
The Primary Objective is to check if squint surgery causes any changes in the strength and flexibility of the front part of the eye (cornea) using the Corvis ST machine before surgery, and again at 1 month and 3 months after surgery While Secondary Objectives are -To compare changes based on the type of surgery -To see if changes differ when one or more muscles are operated. -To check if the type of cut made during surgery (limbal vs forniceal) affects the results. -To find out whether the changes are temporary or long-term. -To see if changes in the cornea relate to any changes in eyesight after surgery.
Expected results- We expect to find temporary changes in corneal strength and flexibility after surgery that should return close to normal within 3 months. Or does type of surgery or incision or number of muscles operated has any effects on outcome of surgery- in turn on postoperative vision. |