| CTRI Number |
CTRI/2023/07/054918 [Registered on: 06/07/2023] Trial Registered Prospectively |
| Last Modified On: |
06/07/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To compare the changes in thickness of outermost layer of cornea in Keratoconus patients and normal individuals using CIRRUS HD OCT machine.
|
|
Scientific Title of Study
|
Assessment of Corneal Epithelial Thickness Mapping in Keratoconus and Normal Eyes using Cirrus HD OCT
|
| 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 Pooja Patil |
| Designation |
Primary DNB post MBBS Ophthalmology |
| Affiliation |
Sankara Eye Hospital |
| Address |
16-A, room no 31, Department of Cornea, Sankara Eye Hospital, Sivanandhapuram, Sathy road, Ganapathy,
Coimbatore (641035)
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9922558432 |
| Fax |
|
| Email |
poojarpatil26@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhu Vijayaraghavan |
| Designation |
Senior Cornea Consultant |
| Affiliation |
Sankara Eye Hospital , Coimbatore |
| Address |
Department of cornea, room no 31, Sankara Eye Hospital, Sivanandhapuram, Sathy road, Ganapathy, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9976488000 |
| Fax |
|
| Email |
drvprabhu@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pooja Patil |
| Designation |
Primary DNB post MBBS Ophthalmology |
| Affiliation |
SankaraEye Hospital, COIMBATORE |
| Address |
Department of cornea, room no 31, Sankara Eye Hospital, Sivanandhapuram, Sathy road, Ganapathy, Coimbatore
Coimbatore
TAMIL NADU
641035
India |
| Phone |
9922558432 |
| Fax |
|
| Email |
poojarpatil26@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 31, Department of Cornea, Sankara Eye Hospital Coimbatore-641035 TAMIL NADU INDIA |
|
|
Primary Sponsor
|
| Name |
Sankara Eye Hospital Coimbatore |
| Address |
Sankara Eye Hospital, Sivanandhapuram, Sathy road, Ganapathy, Coimbatore |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 |
| Dr Pooja R Patil |
Sankara Eye Hospital Coimbatore |
Department of cornea, room no 31, Sankara Eye Hospital, Sivanandhapuram, Sathy road, Ganapathy, Coimbatore
Coimbatore
TAMIL NADU |
9922558432
poojarpatil26@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Sankara Eye Hospital, Coimbatore |
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 |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Topographic findings considered as typical for KC, such as corneal thinning, central or inferior steep zone, and asymmetric bowtie with or without skewed axis astigmatism.
Normal healthy eyes will be included as controls. |
|
| ExclusionCriteria |
| Details |
Previous Ocular surgery or trauma.
Associated corneal pathological features.
A history of collagen cross linking, intrastromal corneal ring segment implantation, keratoplasty, or other corneal surgery.
Contact lens wear during the previous 3 weeks.
Pregnant females . |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the epithelial thickness map changes in keratoconus & normal eyes using Cirrus HD OCT
|
First day of visit (at baseline )
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the epithelial thickness map changes between two eyes of Keratoconus patients with grossly asymmetrical keratoconus |
First day of visit at baseline |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
14/07/2023 |
| 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="4"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 progressive disorder in which central or paracentral corneal stromal thinning occurs, accompanied by apical protrusion and irregular astigmatism. Approximately 50% of normal fellow eyes will progress to KC within 16 years. The changes of corneal epithelium have been hypothesised to develop in the sub clinical stage of Keratoconus. It is assumed that the corneal epithelium has the ability to change or adapt its thickness, thereby maintaining a smooth corneal surface and masking an already ongoing deconstruction of the corneal storma or an underlying cone. Consequently, corneal epithelial thickness maps could be used for the early detection of Keratoconus.
Since significant differences in the corneal epithelial thickness profile have been found even in normal eyes, there is need of studies with large sample size in order to understand whether corneal epithelial mapping could be valuable to detect pathologic changes in eyes with Keratoconus.
Optical Coherence Tomography (AS-OCT) is a safe and non-invasive method of high resolution cross sectional imaging for tissue microstructures using infrared radiation. |