| CTRI Number |
CTRI/2025/04/084324 [Registered on: 07/04/2025] Trial Registered Prospectively |
| Last Modified On: |
05/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To Compare the Outcomes of Accelerated Transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS) in patients with progressive Keratoconus( comparison between two dyes used in corneal cross linking in keratoconus) |
|
Scientific Title of Study
|
To Compare the Outcomes of Accelerated Transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS) in patients with progressive 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 Poppy Debbarma |
| Designation |
Doctor (Junior Resident) |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Post Graduate Institue of Medical Education and Research
Ophthalmology department
Advanced Eye Centre
Room number 312
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8787581612 |
| Fax |
|
| Email |
poppydebbarma24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Chintan Malhotra |
| Designation |
Associate Professor ( Doctor) |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Post Graduate Institue of Medical Education and Research
Ophthalmology
Advanced Eye Centre
Room number 312
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8872016281 |
| Fax |
|
| Email |
drchintansingh@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Poppy Debbarma |
| Designation |
Doctor (Junior Resident) |
| Affiliation |
Post Graduate Institute of Medical Education and Research |
| Address |
Post Graduate Institue of Medical Education and Research
Ophthalmology department
Advanced Eye Centre
Room 312
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8787581612 |
| Fax |
|
| Email |
poppydebbarma24@gmail.com |
|
|
Source of Monetary or Material Support
|
| Post Graduate Institute of Medical Education and Research.
Country : India
State: Chandigarh
Pin code :160012 |
|
|
Primary Sponsor
|
| Name |
Poppy Debbarma |
| Address |
Advanced Eye Centre
Post Graduate Institute of Medical Education and Research |
| Type of Sponsor |
Other [Self] |
|
|
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 Poppy Debbarma |
PGIMER |
Post Graduate Institue of Medical Education and Research
Advanced Eye Centre
Ophthalmology department
Room number 312
Chandigarh
CHANDIGARH |
08787581612
poppydebbarma24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Postgraduate Institute of Medical Education and Research, Chandigarh Institutional Ethics Committee(Intramural) |
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 |
| Comparator Agent |
Riboflavin containing HPMC |
These patients will undergo accelerated TECXL using
9mW/cm2
of continuous UVA exposure for 10 minutes (total fluence 5.4J/cm2
) after the
initial HPMC based riboflavin (PESCHKE TE) soaking phase of 20 minutes. The riboflavin
solution is composed of 0.25 % riboflavin with HPMC 1.2% and 0.01% benzalkonium
chloride to enhance trans epithelial penetration . Riboflavin will be instilled on the cornea
every two minutes during both the soaking and UV exposure phases.
Total duration of study : 6 months
|
| Intervention |
Riboflavin containing Vitamin E Tocopheryl Polyethylene Glycol Succinate(TPGS) |
These patients will undergo accelerated
Transepithelial corneal cross linking using 9mW/cm2
of continuous UVA exposure for 10 minutes (total fluence
5.4J/cm2
) after the initial Vitamin E-TPGS based riboflavin (RIBOFAST) soaking phase
of20 minutes. The riboflavin solution is composed of 0.1% riboflavin , Vit E TPGS as
permeation enhancer, monobasic and bibasic sodium phosphate as buffers , sodium chloride
as isotonizer and purified water as a solvent. Ribofast riboflavin solution will be instilled on
the cornea every minute during both the soaking and UV exposure phases. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Month(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Age 18 years or above
2. Thinnest pachymetry of 360 micrometer or above on Pentacam
3. K-max of 65D or less onScheimpflug imaging with Pentacam
4. Grade 1-3 keratoconus by Belin ABCD classification on Pentacam.
5. Corrected distance visual acuity (CDVA) of less than 20/20 on the Snellen vision
chart
6. Endothelial cell density of 2000 cells/mm2 or above
7. Absence of any ocular surface disorders and other active ocular allergic conditions |
|
| ExclusionCriteria |
| Details |
1. Presence of advanced keratoconus associated with subepithelial scarring
2. History of herpetic keratitis or recurrent corneal erosions
3. Previous corneal surgery
4. Previous history of cross linking
5. Presence of any corneal guttae or other endothelial pathology.
6. Patients who are pregnant or breast feeding.
7. Patients with autoimmune diseases. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Demarcation line depth and visibility to be measured on Swept source OCT at 8 weeks after the CXL procedure
procedure |
8 weeks after the CXL procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in total corneal densitometry at 3 months & 6 months post CXL compared
to pre CXL values
|
3 months & 6 months |
2. Change in maximum keratometry(Kmax) 3 months & 6 months after CXL
compared to pre CXL values
|
3 months & 6 months |
| 3. Change in total corneal Higher order aberrations at 3 months & 6 months |
3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
30/04/2025 |
| 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="0"
Months="6"
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
|
To compare the outcomes of accelerated transepithelial Corneal Cross Linking using HPMC riboflavin versus riboflavin containing Vitamin E Tocopheryl polyethylene glycol succinate(TPGS) in patients with progressive keratoconus. Considering the potential benefits of transepithelial CXL, the reduced time taken by
accelerated CXL without compromising the efficacy and the potency of vitamin E-TPGS
riboflavin to effectively enhance riboflavin penetration, this study aims to evaluate the
outcome of vitamin E-TPGS riboflavin in patients with progressive keratoconus. |