| CTRI Number |
CTRI/2024/06/069279 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
13/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Two Methods of Corneal Treatment in Patients Aged 6-35 with Keratoconus |
|
Scientific Title of Study
|
Comparison of efficacy between accelerated epithelium-off and accelerated epithelium-on corneal collagen crosslinking in patients with keratoconus |
| 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 and Head of Unit |
| Affiliation |
Department of Ophthalmology Maulana Azad Medical College And associated G.N.E.C |
| Address |
Cornea services, Department of Opthalmology, Maulana Azad Medical College and Guru Nanak Eye Centre, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Pushkar Rangari |
| Designation |
PG student |
| Affiliation |
Department of Ophthalmology Maulana Azad Medical College And associated G.N.E.C |
| Address |
Department of Opthalmology, Maulana Azad Medical College and Guru Nanak Eye Centre, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9820089224 |
| Fax |
|
| Email |
pushkarrangari@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Pushkar Rangari |
| Designation |
PG student |
| Affiliation |
Department of Ophthalmology Maulana Azad Medical College And associated G.N.E.C |
| Address |
Department of Opthalmology, Maulana Azad Medical College and Guru Nanak Eye Centre, New Delhi-110002
Central
DELHI
110002
India |
| Phone |
9820089224 |
| Fax |
|
| Email |
pushkarrangari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Opthalmology
Maulana Azad Medical College and Guru Nanak Eye Centre, New Delhi Pin-110002
|
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College and associated Hospitals Guru nanak eye centre |
| Address |
Maulana Azad Medical College and associated hospitals Guru nanak eye centre, New Delhi, Pin-110002 |
| 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 Pushkar Rangari |
Guru Nanak Eye Centre |
Room 101, Department of Opthalmology, Cornea services,
Maulana Azad Medical College and associated hospitals Guru Nanak Eye Centre, New Delhi PIN-110002
Central
DELHI |
9820089224
pushkarrangari@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad medical college Institutional ethics committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H186||Keratoconus, (2) ICD-10 Condition: H186||Keratoconus, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
C3R using isotonic riboflavin dye |
performing epi off C3R using isotonic riboflavin dye. Isotonic dye 1 drop every 3 minutes for 30 minutes followed by irradiation for 10 minutes with the dye in the same frequency of 1 drop every 3 minutes |
| Intervention |
C3R using Ribofast dye |
performing epi on C3R using ribofast dye. dye application 1 drop every minute for 30 minutes followed UV irradiation for 10 minutes with ribofast dye 1 drop per minute during irradiation |
|
|
Inclusion Criteria
|
| Age From |
6.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1)Central corneal thickness more than 400 microns at the thinnest point |
|
| ExclusionCriteria |
| Details |
a)Patients with history of trauma and prior ocular surgery
b)Corneal scar or history of herpetic keratitis
c)Active vernal keratoconjunctivitis
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1)Change in maximum keratometry (Kmax) at 6 months |
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)Demarcation line on anterior segment OCT at 1 month
2)Change in best corrected visual acuity (BCVA) at 6months
3)Endothelial cell density at 6 months
|
1 month,6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
29/06/2024 |
| Date of Study Completion (India) |
31/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
This Prospective, randomized, comparative study compares the efficacy between accelerated epithelium-off and accelerated epithelium-on corneal collagen crosslinking in patients
with keratoconus. It would be conducted at Guru Nanak Eye Centre, comprising 2 groups of 25 patients per group. The primary outcome is to observe the change in maximum keratometry (Kmax) at 6 months and the secondary objective is to observe the demarcation line on anterior segment OCT at 1 month, change in best corrected visual acuity (BCVA) at 6 months and endothelial cell density at 6 months |