| CTRI Number |
CTRI/2022/01/039821 [Registered on: 28/01/2022] Trial Registered Prospectively |
| Last Modified On: |
26/01/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Corneal Evaluation in Early Keratoconus |
|
Scientific Title of Study
|
Study of Corneal Biomechanics in Subclinical/Forme Fruste Keratoconus |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEGHNA GANESH |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
GURU NANAK EYE CENTER |
| Address |
GURU NANAK EYE CENTER
MAHARAJA RANJIT SINGH MARG
NEW DELHI
Central
DELHI
110002
India |
| Phone |
9910022147 |
| Fax |
0 |
| Email |
meghna15ganesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR RITU ARORA |
| Designation |
DEAN MAMC |
| Affiliation |
GURU NANAK EYE CENTER |
| Address |
DEAN OFFICE
MAULANA AZAD MEDICAL COLLEGE
BAHADUR SHAH ZAFAR MARG
NEW DELHI
Central
DELHI
110002
India |
| Phone |
9810371022 |
| Fax |
0 |
| Email |
dr_rituarora@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MEGHNA GANESH |
| Designation |
POST GRADUATE RESIDENT |
| Affiliation |
GURU NANAK EYE CENTER |
| Address |
GURU NANAK EYE CENTER
MAHARAJA RANJIT SINGH MARG
NEW DELHI
DELHI
110002
India |
| Phone |
9910022147 |
| Fax |
0 |
| Email |
meghna15ganesh@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Guru Nanak Eye Centre |
| Address |
GURU NANAK EYE CENTRE
MAHARAJA RANJIT SINGH MARGH
NEW DELHI 110002 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
ALL INDIA INSTITUTE OF MEDICAL SCIENCES
ANSARI NAGAR
NEW DELHI 110029 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| MEGHNA GANESH |
GURU NANAK EYE CENTRE |
Room 12
GURU NANAK EYE CENTRE
DEPARTMENT OF OPHTHALMOLOGY
MAHARAJA RANJIT SINGH MARGH
NEW DELHI
Central
DELHI |
9910022147
0
meghna15ganesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MAMC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Age matched subjects with/without refractive errors |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1)Fellow eyes of frank keratoconus cases or cases with topography suggestive of keratoconus and vision 6/6.
2)Eyes of normal subjects(any age group) without any prior ocular morbidity.
3)Subjects with refractive errors. |
|
| ExclusionCriteria |
| Details |
1)Patients not willing to participate in the study.
2)Eyes with clinically diagnosed keratoconus.
3)Patients with history of trauma, prior ocular surgery, corneal scars and other ocular co-morbidities.
4)Pregnant and lactating mothers.
5)Cross linked eyes. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TBI(Tomographic and Biomechanical Index) |
12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To identify parameters of significance in early detection of altered corneal biomechanics |
12 months |
|
|
Target Sample Size
|
Total Sample Size="48"
Sample Size from India="48"
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)
|
01/02/2022 |
| 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)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
My Study is a cross sectional observational study to study the corneal biomechanical parameters in eyes with subclinical/forme fruste keratoconus and in normal eyes and to identify parameters of significance in early detection of altered corneal biomechanics. |