| 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
|
|
|
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. |