| CTRI Number |
CTRI/2023/05/052622 [Registered on: 15/05/2023] Trial Registered Prospectively |
| Last Modified On: |
25/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Surgical/Anesthesia |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Phase I Clinical trial for bioengineered decellularised cross-linked human corneal graft : A novel therapeutic approach to combat corneal blindness in India. |
|
Scientific Title of Study
|
Phase I Clinical trial study to explore the feasibility and evaluate the clinical outcomes and safety of keratoplasty using bioengineered decellularized cross-linked human corneal graft in comparison to fresh human corneas: A novel therapeutic approach to combat corneal blindness in India. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Radhika Tandon |
| Designation |
Professor of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences(AIIMS) |
| Address |
Room no 490, 4th floor,
Dept of Ophthalmology,
Dr. Rajendra Prasad Center for Ophthalmic Sciences,
All India Institute of Medical Sciences(AIIMS),
Ansari Nagar
New Delhi.
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
radhika_tan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Radhika Tandon |
| Designation |
Professor of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences(AIIMS) |
| Address |
Room no 490, 4th floor,
Dept of Ophthalmology,
Dr. Rajendra Prasad Center for Ophthalmic Sciences,
All India Institute of Medical Sciences(AIIMS),
Ansari Nagar
New Delhi.
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
radhika_tan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Radhika Tandon |
| Designation |
Professor of Ophthalmology |
| Affiliation |
All India Institute of Medical Sciences(AIIMS) |
| Address |
Room no 490, 4th floor,
Dept of Ophthalmology,
Dr. Rajendra Prasad Center for Ophthalmic Sciences,
All India Institute of Medical Sciences(AIIMS),
Ansari Nagar
New Delhi.
South
DELHI
110029
India |
| Phone |
|
| Fax |
|
| Email |
radhika_tan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Delhi |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, Delhi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Prof Radhika Tandon |
DR RAJENDRA PRASAD CENTRE, All India Institute of medical Sciences |
Room no 490, 4th floor,
Dept of Ophthalmology,
Dr. Rajendra Prasad Center for Ophthalmic Sciences
South
DELHI |
01126593145
radhika_tan@yahoo.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, AIIMS, Delhi |
Approved |
| INSTITUTE ETHICS COMMITTEE, All India Institute Of Medical Sciences |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Decellularised bioengineered cross-linked human corneal graft |
Intervention will be the use of bioengineered corneas.Lamellar keratoplasty (LK) will be performed for replacing the damaged cornea in infectious keratitis cases and corneal opacity cases. The intervention cases will be operated using the bioengineered decellularised preserved cornea (intervention agent) |
| Comparator Agent |
Fresh human cornea |
Intervention will be the use of fresh human corneas. Lamellar keratoplasty (LK) will be performed for replacing the damaged cornea in infectious keratitis cases and corneal opacity cases. The comparator agent will be fresh human corneas. |
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. Age aged 18 years of age or above
2. Unilateral/ bilateral infectious keratitis or corneal opacity, satisfying the following criteria:
[The patients undergoing emergency partial-thickness keratoplasty for corneal infections (severe corneal ulcers or melts, with depth <80% of corneal thickness and size < 7mm) or corneal opacities (with depth of opacities upto 400 µm)]
3. Willing to participate and follow-up for at least 6 months
4. Patient who able to give consent for the intervention. In cases where the patient is not able to give consent, then Legal Acceptable Representative (LAR) will do the same on behalf of patients.
|
|
| ExclusionCriteria |
| Details |
b) Exclusion Criteria:
1. Those with corneal thickness <450 µm
2. Those with limbus-to-limbus extent of corneal infection.
3. Patients with untreated concurrent ocular conditions, such as adnexal problems, adnexal infections, retinal pathology and glaucoma |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| healing of ulcer, maintenance of glove integrity |
Months 1,3,6 and 12 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Best corrected visual acuity |
Months 1,3,6 and 12 |
| survival of the graft (status of graft clarity or transparency, rate of epithelisation of graft, neovascularization) |
Months 1,3,6 and 12 |
| safety data (any ocular complication noticed after surgery) |
Months 1,3,6 and 12 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="20"
Sample Size from India="20"
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
Modification(s)
|
Phase 1 |
|
Date of First Enrollment (India)
|
01/07/2023 |
| 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)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
This clinical trial aims to evaluate the feasibility, safety, and tolerability of bioengineered, decellularized, and cross-linked human corneal grafts for keratoplasty in patients with corneal infections and corneal opacity with a comparison of outcomes from fresh human corneal grafts. As an academic clinical trial- Phase I (pilot clinical study), study focuses on assessing the safety and feasibility of decellularized bioengineered corneal grafts based on primary and secondary outcomes. |