FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/11/097572 [Registered on: 17/11/2025] Trial Registered Prospectively
Last Modified On: 04/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To study the corneal stiffness map in Normal eyes, Keratoconic eyes and patients with Diabetes 
Scientific Title of Study   Evaluation of Corneal Biomechanics: Stress-Strain Index (SSI) Mapping Using Corvis ST in Normal, Diabetic, and Keratoconic Patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrPrema Padmanabhan 
Designation  Distinguished Senior Consultant 
Affiliation  Medical Research Foundation 
Address  New No.41 Old No.18 Medical Research Foundation Sankara Nethralaya College Road Chennai 600 006.

Chennai
TAMIL NADU
600006
India 
Phone  9176681588  
Fax    
Email  drpp@snmail.org  
 
Details of Contact Person
Scientific Query
 
Name  DrPrema Padmanabhan 
Designation  Distinguished Senior Consultant 
Affiliation  Medical Research Foundation 
Address  New No.41 Old No.18 Medical Research Foundation Sankara Nethralaya College Road Chennai 600 006.


TAMIL NADU
600006
India 
Phone  9176681588  
Fax    
Email  drpp@snmail.org  
 
Details of Contact Person
Public Query
 
Name  Sapna Yadav 
Designation  Master of Optometry Student 
Affiliation  Medical Research Foundation 
Address  New No.41 Old No.18 Medical Research Foundation Sankara Nethralaya College Road Chennai 600 006.

Chennai
TAMIL NADU
600006
India 
Phone  8810384844  
Fax    
Email  sapnayadhuvanshi0@gmail.com  
 
Source of Monetary or Material Support  
Medical Research Foundation Sankara Nethralaya Medical Research Foundation New No 41 Old No 18 College Road Chennai 600 006 Tamil Nadu, India  
 
Primary Sponsor  
Name  Medical Research Foundation 
Address  Medical Research Foundation New No 41 Old No 18 College Road Chennai 600 006 Tamil Nadu, India  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
DrDaniela Oehring  University of Plymouth United Kingdom 
DrElsheikh Ahmed  University of Liverpool United Kingdom 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prema Padmanabhan  Medical Research Foundation  New No.41 Old No.18 Medical Research Foundation Sankara Nethralaya College Road Chennai 600 006.
Chennai
TAMIL NADU 
9176681588

drpp@snmail.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Review Board-Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Keratoconus Diabetes Mellitus 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Normal Group
Age 20 to 70 years
Best corrected visual acuity of 20/25 or better
Normal corneal topography and tomography
Refractive error within plus or minus 5.0 D spherical and plus or minus 3.0 D cylindrical
Keratoconus Group
Age 18 to 45 years
Clinical diagnosis of keratoconus
KC staging according to ABCD grading system
No previous corneal surgery including CXL
Diabetic Group
Age 30 to 70 years
Type 1 or Type 2 diabetes mellitus diagnosis
Diabetes duration equal to or greater than 5 years
Recent HbA1c value within 3 months
Stable glycemic control for equal to or greater than 3 months
 
 
ExclusionCriteria 
Details  All Groups
Previous ocular surgery (including CXL, PRK, LASIK, cataract surgery)
Active ocular infection or inflammation
Corneal scarring or opacity
Glaucoma or ocular hypertension (IOP greater than 21 mmHg)
Pregnancy or breastfeeding
Contact lens wear (soft lenses washout 2 weeks, RGP washout 4 weeks)
Systemic medications affecting cornea (e.g., amiodarone, isotretinoin)
Connective tissue disorders (e.g., Marfan syndrome, Ehlers-Danlos)

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Global SSI differences and regional SSI map metrics  Baseline, 3, 6, 9, and 12 months for the Longitudinal Sub Group 
 
Secondary Outcome  
Outcome  TimePoints 
Diagnostic performance (AUC, sensitivity, specificity), age–SSI correlation   
 
Target Sample Size   Total Sample Size="470"
Sample Size from India="470" 
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)   01/12/2025 
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)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

The Corneal Visualization Scheimpflug Technology by Oculus is a non-contact device that assesses corneal biomechanics by using a high-speed Scheimpflug camera to capture the cornea’s response to an air puff. The corneal biomechanical properties play a crucial role in maintaining ocular shape and visual function. Corneal stiffness, which reflects the resistance of the cornea to deformation, is influenced by factors such as intraocular pressure, collagen structure, and extracellular matrix composition. Understanding the biomechanical behavior of the cornea is essential for accurate diagnosis, monitoring, and management of various corneal disorders.

 

The Stress-Strain Index is a biomechanical parameter that quantifies corneal stiffness by measuring the relationship between stress and strain provided by the Corvis ST to estimate the overall stress–strain behavior of corneal tissue. With this information, the tangent modulus, a measure of the tissue’s material stiffness, could be estimated at any load or stress. This point is of particular importance since biological tissues have nonlinear stress–strain behavior, which means that Et does not have a unique value but increases with applied load and the corresponding deformation.

 

SSI mapping, performed using the Corvis ST, provides a non-invasive method to evaluate corneal biomechanics by analyzing the cornea’s dynamic response to an air puff. This work uses Corvis ST to map the SSI in a cohort of healthy people in order to assess age-related changes in corneal biomechanics. The selection criteria for refractive and corneal procedures will be improved, diagnostic accuracy for corneal disorders will be increased, and important insights into corneal health will be gained from an understanding of how corneal stiffness varies with age. The results of this study will help create age-specific normative data for SSI, which may be used as a clinical reference for upcoming treatments and diagnostic procedures.

 

Diabetes is a systemic metabolic disease associated with high morbidity and mortality that can affect almost all tissues of the human body, including the most superficial and transparent ocular tissue: the cornea. Diabetes can have a variety of effects on the cornea, frequently without any outward symptoms in the early stages. Because of the accumulation of dangerous chemicals known as advanced glycation end-products, persistently elevated blood sugar levels can alter the cornea’s rigidity and structure. Before any obvious damage happens, SSI mapping assists diabetic patients in detecting early alterations in the cornea’s biomechanics. It also helps assess corneal stiffness between diabetic and non-diabetic persons, and between patients with good and poor blood sugar control. SSI mapping can help us better understand how diabetes impacts the cornea and promote more individualized, high-quality eye treatment. By assessing SSI in relation to HbA1c levels or disease duration, clinicians may gain insight into how metabolic control influence corneal biomechanics. This makes SSI mapping a potentially valuable tool for monitoring the ocular effects of diabetes and tailoring individualized eye care strategies.

 

Keratoconus is a progressive corneal disease that usually affects the central and paracentral cornea and is characterized by localized thinning and biomechanical weakening. A single worldwide indicator of corneal stiffness is provided by the stress-strain index, which is derived from the Corvis ST. However, a spatial SSI map that shows changes in stiffness throughout the corneal surface can be created by combining this with geometric data and the known distribution of collagen fibrils. This makes it possible to see the biomechanical variations between the cone and the surrounding tissue, providing a better understanding of how disease behave. Thus, SSI mapping is essential for comprehending the evolution of keratoconus, improving early detection and staging, and detecting individualized therapy techniques like cross-linking. A single SSI value obtained from the Corvis ST for an eye, either healthy or KC, could be translated into a map by adding geometric information and using knowledge about collagen fibril density to show the variation of SSI across corneal surface. This map could enable visualization of the effect of the disease on the affected area, and help improve fundamental understanding of the mechanics of keratoconus progression in individual patients.

 
Close