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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  
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 
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  
Status 
Not Applicable 
 
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.
 
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