| CTRI Number |
CTRI/2020/11/028858 [Registered on: 03/11/2020] Trial Registered Prospectively |
| Last Modified On: |
03/11/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Feasibility of Novel Grafts for Emergency Corneal replacement |
|
Scientific Title of Study
|
Use of Gamma-Irradiated, Pre-cut Corneal Lenticules for Tectonic Keratoplasty in Patients with perforated corneal disease – A pilot study |
| Trial Acronym |
GATE |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AEH/PDY/EC/OA/70/2019 Version 1 Date 15/05/2019 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Josephine Christy |
| Designation |
Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 25
Department of Cornea and Refractive Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007
Pondicherry
PONDICHERRY
605007
India |
| Phone |
9994549584 |
| Fax |
|
| Email |
josephine@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Josephine Christy |
| Designation |
Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 25
Department of Cornea and Refractive Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007
PONDICHERRY
605007
India |
| Phone |
9994549584 |
| Fax |
|
| Email |
josephine@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Josephine Christy |
| Designation |
Consultant |
| Affiliation |
Aravind Eye Hospital |
| Address |
No 25
Department of Cornea and Refractive Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007
PONDICHERRY
605007
India |
| Phone |
9994549584 |
| Fax |
|
| Email |
josephine@aravind.org |
|
|
Source of Monetary or Material Support
|
| Aravind Eye Hospital
Pondicherry |
|
|
Primary Sponsor
|
| Name |
Aravind Eye Hospital Pondicherry |
| Address |
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| CorneaGen |
1200 6th Ave
Ste 300
Seattle
WA 98101 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Josephine Christy |
Aravind Eye Hospital |
No 25
Department of Cornea and Refractive Services
Aravind Eye Hospital
Cuddalore Main Road
Thavalakuppam
Pondicherry 605007
Pondicherry
PONDICHERRY |
9994549584
josephine@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Aravind Eye Hospital Pondicherry |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H160||Corneal ulcer, (2) ICD-10 Condition: H168||Other keratitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
No comparator agent used in this study as this is a single arm pilot study |
The results will be compared with outcomes of fresh donor corneal tissue existing in previous literature |
| Intervention |
Tectonic Keratoplasty |
Emergency Tectonic Keratoplasty for patients with perforated corneal disease due to infection or trauma
It is a 45 minutes surgery which will be done within 48 hours of recruitment of study patients |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Perforated corneal ulcer of size – more than 6 mm but with at least 2 mm clear margin from limbus |
|
| ExclusionCriteria |
| Details |
Patients with potential good visual outcome with normal corneal transplants – Ulcer size less than 6mm
Mono-ocular patient with other eye vision less than 6/60
Co-existing endophthalmitis or retinal detachment requiring retinal procedures
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Anatomical success - the restoration of tectonic integrity of globe
Therapeutic success - defined as complete eradication of primary infection after keratoplasty with appropriate adjunctive medical therapy
|
1 month and 6 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Functional success - preservation of visual function with post op BCVA ranging from perception of light (PL), accurate projection of rays (PR) to 20/40
Complications
Re-Surgeries like AC wash or AC reformation
Adjunctive surgical procedures for graft epithelial healing
Recurrent infection
Recurrent perforation or graft melt
Graft failure
Glaucoma
|
At 1 month and 6 months |
|
|
Target Sample Size
|
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
|
N/A |
|
Date of First Enrollment (India)
|
01/12/2020 |
| 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 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
|
Summary Corneal blindness in India is one of the leading cause of bilateral blindness. 1.5-2 million people develop corneal ulcer annually and large proportion of these ulcers progress to perforation, resulting in severe ocular morbidities and even loss of globe. Such cases require an emergency surgery called therapeutic penetrating keratoplasty (TPK). Regrettably, there is a drastic mismatch between supply and demand of donor corneas worldwide, with only 1 cornea available for every 70 needed.
Primary objective of this study is to determine the feasibility of using gamma-irradiated corneal tissue for emergency keratoplasty in patients with corneal perforation. Main advantage of these tissues are, they can be stored at room temperature for up to two years and can be used by any ophthalmologist across the country reducing the dependency on eye banks. It has been successfully used for lamellar keratoplasty in western countries, but this will be the first prospective study for emergency TPK.
Expected Outcome The ability to use long-term preserved corneal
tissue/GICL might represent a means of relieving the burden of corneal
blindness particularly in the developing world
And it offers an expansion of supply of donor
corneal tissue because of its advantages like
Ready availability
Long term storage capability at room temperature
Ease of use |