| CTRI Number |
CTRI/2024/01/062144 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
23/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [C3R] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two different methods of crosslinking for pediatric Keratoconus patients with thin corneas |
|
Scientific Title of Study
|
Comparison of efficacy of corneal collagen crosslinking using contact lens versus hypoosmolar riboflavin in pediatric keratoconus 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 |
Dr. Parul Jain |
| Designation |
associate Professor,Guru Nanak Eye Centre |
| Affiliation |
Guru Nanak Eye Centre, Delhi.. |
| Address |
Room no 35, Cornea services, Ward building, Guru Nanak Eye Centre, Maulana Azad Medical college , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Gahan Reddy A |
| Designation |
PG student, Guru Nanak Eye Centre |
| Affiliation |
Guru Nanak Eye Centre, Maulana Azad Medical college , New Delhi |
| Address |
Guru Nanak Eye Centre ,Pediatric ophthalmology and Cornea Unit, Room number 52 on Monday, Thursday ,Maulana Azad Medical college , New Delhi
New Delhi
DELHI
110002
India |
| Phone |
9704092351 |
| Fax |
|
| Email |
gahanreddya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr.Gahan Reddy |
| Designation |
PG student |
| Affiliation |
Guru Nanak Eye Centre, Maulana Azad Medical college , New Delhi |
| Address |
Guru Nanak Eye Centre,Pediatric ophthalmology and cornea unit, room number 52 on Monday and Thursday, Maulana Azad Medical college , New Delhi
DELHI
110002
India |
| Phone |
9704092351 |
| Fax |
|
| Email |
gahanreddya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Guru Nanak Eye Centre, Maulana Azad Medical college , New Delhi |
|
|
Primary Sponsor
|
| Name |
Guru Nanak Eye Centre, Maulana Azad Medical college , New Delhi |
| Address |
Guru Nanak Eye Centre, Maulana Azad Medical college , New Delhi |
| Type of Sponsor |
Government medical college |
|
|
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 Parul Jain |
Guru Nanak Eye Centre, Maulana Azad Medical college |
Guru Nanak Eye Centre,Room 52 on monday, thursday , Maulana Azad Medical college, Maharaja Ranjit Singh Marg, New Delhi
New Delhi
DELHI |
9971927902
Pjain811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethic commiittee |
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 |
Contact lens assisted c3r |
Crosslinking in Keratoconus patients with thin corneas using contact lens to increase thickness.. one operation assessed after 6 months.. |
| Comparator Agent |
Hypoosmolar crosslining |
Crosslinking in Keratoconus patients with thin corneas using hypoosmolar riboflavin to increase thickness .. one operation assessed after 6 months.. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
All pediatric patients with thin corneas |
|
| ExclusionCriteria |
| Details |
Active allergy
Active infection coexisting
ocular disease |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in maximum keratometry at 6 months |
Change in maximum keratometry at 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Change in bcva at 6 months
Change in endothelial cell density at 1 month
Demarcation line in ASOCT at 1 month |
1 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
29/04/2024 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
To compare of efficacy and safety of contact lens assisted corneal collagen crosslinking(CL-CXL) and accelerated corneal collagen crosslinking using hypoosmolar riboflavin (H-ACXL) in paediatric patients with keratoconus with thin cornea. |