| CTRI Number |
CTRI/2025/11/097923 [Registered on: 24/11/2025] Trial Registered Prospectively |
| Last Modified On: |
21/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Study of the inner corneal layer in people with cone shaped cornea using a special eye microscope |
|
Scientific Title of Study
|
Study of Corneal Endothelium in eyes with Keratoconus using Specular Microscope |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Shayreen Naz |
| Designation |
Secondary DNB Resident |
| Affiliation |
Sankara Eye hospital, Shimoga |
| Address |
Room no 11, Clinical Demonstration room,Sankara Eye Hospital, Thirthahalli, Gandharva Nagara Road, Harakere
Shimoga
KARNATAKA
577202
India |
| Phone |
7268003404 |
| Fax |
|
| Email |
shayreen.naz@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Roopasree B V |
| Designation |
Senior Consultant, Cornea |
| Affiliation |
Sankara Eye hospital, Shimoga |
| Address |
Room no 11, Clinical Demonstration room,Sankara Eye Hospital, Thirthahalli, Gandharva Nagara Road, Harakere
Shimoga
KARNATAKA
577202
India |
| Phone |
8884920286 |
| Fax |
|
| Email |
dr.roopasree@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Shayreen Naz |
| Designation |
Secondary DNB Resident |
| Affiliation |
Sankara Eye hospital, Shimoga |
| Address |
Room no 11, Clinical Demonstration room,Sankara Eye Hospital, Thirthahalli, Gandharva Nagara Road, Harakere
Shimoga
KARNATAKA
577202
India |
| Phone |
7268003404 |
| Fax |
|
| Email |
shayreen.naz@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sankara Eye Hospital, Thirthahalli, Gandharva Nagara Road, Harakere, Shivamogga, Karnataka, 577202 |
|
|
Primary Sponsor
|
| Name |
Dr Shayreen Naz |
| Address |
Room no 11, Clinical Demonstration room, Sankara Eye Hospital, Thirthahalli, Gandharva Nagara Road, Harakere, Shimoga, Karnataka, 577202 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shayreen Naz |
Sankara Eye Hospital |
Room no 11, Clinical Demonstration room
Shimoga
KARNATAKA |
7268003404
shayreen.naz@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, Shimoga |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1)Patient age 8 to 40 years
2)Topographically diagnosed Keratoconus patients
3)Patient willing to give consent for study
4)Patient with clear central cornea |
|
| ExclusionCriteria |
| Details |
1)Patient not willing to give the consent for the study
2) Patient with altered Endothelium morphology
a. Previous ocular surgeries
b.Contact lens use
c.Previous collagen cross-linking
d.Coexisting ocular disease like Glaucoma, Uveitis, Fuchs Endothelial Dystrophy
3) Patient with inability to capture Endothelium image
a. Acute hydrops
b.Corneal opacities or scarring
c.Stage 4 Keratoconus with scarring
d.Poor fixation or Uncooperative patient |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study corneal endothelial cells in eyes with Keratoconus using specular microscope |
At presentation (baseline) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare parameters in different stages of Keratoconus |
At presentation (baseline) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
04/12/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
04/12/2025 |
| 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
|
Keratoconus is a bilateral and asymmetric disease which results in progressive thinning and cone like steepening of cornea leading to irregular astigmatism and decreased visual acquity. It primarily affects adolescence and early adulthood. Corneal endothelium is a single layer of uniformed cells having a hexagonal shape and covers the posterior surface of cornea. Its function is to stabilize the hydration of cornea and maintain its transparency. Specular Microscopy is a non-invasive, non-contact diagnostic tool for imaging of corneal endothelium morphological characteristics. The endothelial health is interpreted with parameters such as percentage of hexagonal endothelial cells, coefficient of variation of cell area and endothelial cell density. This study is being chosen because there is a gap in existing literature regarding this topic. The purpose of this study is to study the health of corneal endothelial cells in topographically diagnosed Keratoconus patient and thereby modifying treatment decisions and hence improving patient outcomes.
|