| CTRI Number |
CTRI/2024/04/066331 [Registered on: 25/04/2024] Trial Registered Prospectively |
| Last Modified On: |
23/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
The changes in the Corneal endothelial layer of the eyes of patients with keratoconus who are currently using scleral lens |
|
Scientific Title of Study
|
Corneal endothelial changes in scleral lens wearers in keratoconic eyes. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shruti Dagar |
| Designation |
Optometrist |
| Affiliation |
The Sankara Nethralaya Academy |
| Address |
Department of Contact lens, 41 Old No 18,
College Rd, Nungambakkam, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU
600006
India
Chennai
TAMIL NADU
600006
India |
| Phone |
8585925728 |
| Fax |
|
| Email |
shrutidagar54@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shruti Dagar |
| Designation |
Optometrist |
| Affiliation |
The Sankara Nethralaya Academy |
| Address |
Department of Contact lens, 41 Old No 18,
College Rd, Nungambakkam, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU
600006
India
TAMIL NADU
600006
India |
| Phone |
8585925728 |
| Fax |
|
| Email |
shrutidagar54@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shruti Dagar |
| Designation |
Optometrist |
| Affiliation |
The Sankara Nethralaya Academy |
| Address |
Department of Contact lens, 41 Old No 18,
College Rd, Nungambakkam, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU
600006
India
TAMIL NADU
600006
India |
| Phone |
8585925728 |
| Fax |
|
| Email |
shrutidagar54@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical Research Foundation, Department of Contact lens, 41 Old No 18,
College Rd, Nungambakkam, Chennai, Tamil Nadu 600006 |
|
|
Primary Sponsor
|
| Name |
Medical Research Foundation |
| Address |
Medical Research Foundation, 41 Old No 18, College Rd,
Nungambakkam, Chennai, Tamil Nadu 600006 |
| Type of Sponsor |
Research institution |
|
|
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 |
| MR ASIF |
Medical Research Foundation, DEPARTMENT OF CL |
DEPARTMENT OF CL, Medical Research Foundation, 41 Old No 18, College Rd,
Nungambakkam, Chennai, Tamil Nadu 600006
Chennai
TAMIL NADU |
8585925728
shrutidagar54@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INstitutional Review board (Medical research foundation Institutional Review Board- ethics committee) |
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 |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participants directly fitted with scleral lens in at least one
eye without any previous history of using any other
modality lenses other than scleral lenses. Must have
had measurements taken before and after initiation of SL
wear |
|
| ExclusionCriteria |
| Details |
Active inflammatory or infective disease. having fuchs dystrophy, ACUTE hydrops or ocular trauma or surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
There will be changes as per the sample size
calculation to determine the effect of intervention
that can be INCREASE OR decrease in the
corneal endothelial INCLUDING COEFFFICIENT
OF VARIATION, HEX SCORE AND CELL
COUNT OF CORNEAL ENDOTHELIAL |
At 6 months and then at 1 year and 3 years the data will be recorded |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
secondary outcome is the same as my primary
outcome which is an event, variable, or
experience as the primary outcome, but
measured at time-points other than those of
primary interest which is now 1 year There will
be changes-INCREASE OR DECREASE in the
corneal endothelial INCLUDING COEFFFICIENT
OF VARIATION, HEX SCORE AND CELL
COUNT OF CORNEAL ENDOTHELIALIN LONG
TERM WEARERS |
WILL BE SEEN at baseline then AFTER 1
YEARS AND 5 YEARS AS WELL |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
22/05/2024 |
| 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="1"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
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
|
Aim is to evaluate the corneal endothelial changes in scleral lens wearers in keratoconic eyes. It is a retrospective study where the data in hospital EMR will be used from 5 years back to find the difference in the endothelial with specular microscopy. This might indicate that scleral lens are useful and may have an effect on endothelial layer by protecting it or the cell count may decrease by wearing contact lens. |