| CTRI Number |
CTRI/2024/01/061566 [Registered on: 18/01/2024] Trial Registered Prospectively |
| Last Modified On: |
16/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To find out the effectiveness of collagen cross-linking using individualized fluence settings based on each patients corneal thickness in patients of keratoconus with thin cornea. |
|
Scientific Title of Study
|
To evaluate the efficacy of collagen cross-linking with individualized fluence (sub 400 protocol) in keratoconus patient with ultrathin cornea. |
| 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 |
| Affiliation |
Maulana Azad Medical College |
| Address |
Cornea clinic, Department of Ophthalmology,
Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Parul Jain |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Cornea clinic, Department of Ophthalmology,
Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Parul Jain |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Cornea clinic, Department of Ophthalmology,
Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, New Delhi
Central
DELHI
110002
India |
| Phone |
9971927902 |
| Fax |
|
| Email |
pjain811@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cornea clinic, Department of Ophthalmology,
Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, Delhi-110002 |
|
|
Primary Sponsor
|
| Name |
Dr Parul Jain |
| Address |
Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, LNJP Colony, New Delhi |
| 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 Parul Jain |
Guru Nanak Eye Centre |
Cornea services, Department of Ophthalmology,Guru Nanak Eye Centre, Maharaja Ranjit Singh Marg, LNJP Colony, New Delhi
New Delhi
DELHI |
9971927902
pjain811@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Institutional Ethics Committee, Maulana Azad Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Collagen Crosslinking using individualized fluence |
In this study, the algorithm of Collagen crosslinking will be used to individualize irradiation settings based on each patient’s minimal corneal thickness at the end of riboflavin soaking but immediately before administering Ultraviolet-A irradiation. The total time for the procedure would be 1 hour |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Cases of keratoconus with epithelium-on corneal stromal thickness of < 400µm. |
|
| ExclusionCriteria |
| Details |
1. Active and severe vernal keratoconjunctivitis/Atopic keratoconjunctivitis
2. Previous keratitis/corneal scars
3. Pregnancy or lactating women
4. Preexisting ocular trauma
5. Previous ocular surgeries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in maximum keratometry (Kmax) |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Demarcation line on Anterior Segment OCT (ASOCT) |
1 month |
| Change in Best Corrected Visual Acuity (BCVA) |
1 year |
| Endothelial cell count |
1 year |
|
|
Target Sample Size
|
Total Sample Size="25"
Sample Size from India="25"
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)
|
27/01/2024 |
| 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="0"
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [pjain811@gmail.com].
- For how long will this data be available start date provided 01-12-2023 and end date provided 01-12-2024?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
Keratoconus is a chronic progressive ophthalmic disease that leads to bulging and thinning of the cornea, resulting in increasing irregular astigmatism and ultimately poor vision. The introduction of collagen cross inking (CXL) has changed the natural course of this disease and as a result reduced the need for corneal transplants. Corneas with advanced disease that would likely benefit from undergoing CXL cannot be treated with the Dresden protocol because of corneal thickness less than 400 microns. The sub400 protocol approach in ultrathin corneas will broaden the range of indications of CXL and further decrease the need for corneal transplantations. |