| CTRI Number |
CTRI/2024/03/064249 [Registered on: 15/03/2024] Trial Registered Prospectively |
| Last Modified On: |
14/03/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison between new and old surgical technique for donor eye collection |
|
Scientific Title of Study
|
A multicentric randomised control trial comparing percentage of optical grade donor human corneas and endotheial cell density between traditional and modified corneoscleral rim excision techniques- a surgical technique trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Charuta J Puranik |
| Designation |
Senior Consultant Ophthalmologist |
| Affiliation |
Oculus Regenerus Eye Care and Research Center |
| Address |
Shop No 3 and 4, SuJay Eye Hospital, Oculus Regenerus Eye Care and Research Center, Moghal My Choice, Nanalnagar, Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
9819473633 |
| Fax |
|
| Email |
charuta.j.p17@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Charuta J Puranik |
| Designation |
Senior Consultant Ophthalmologist |
| Affiliation |
Oculus Regenerus Eye Care and Research Center |
| Address |
Shop No 3 and 4, SuJay Eye Hospital, Oculus Regenerus Eye Care and Research Center, Moghal My Choice, Nanalnagar, Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
9819473633 |
| Fax |
|
| Email |
charuta.j.p17@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Charuta J Puranik |
| Designation |
Senior Consultant Ophthalmologist |
| Affiliation |
Oculus Regenerus Eye Care and Research Center |
| Address |
Shop No 3 and 4, SuJay Eye Hospital, Oculus Regenerus Eye Care and Research Center, Moghal My Choice, Nanalnagar, Hyderabad
Hyderabad
TELANGANA
500008
India |
| Phone |
9819473633 |
| Fax |
|
| Email |
charuta.j.p17@gmail.com |
|
|
Source of Monetary or Material Support
|
| Oculus Regenerus Eye Care and Research Center, Shop no 4, Moghal My Choice Complex, 12-2-718/3A, below Central book point, Nanal Nagar, Mehdipatnam, Hyderabad, Telangana 500008 |
|
|
Primary Sponsor
|
| Name |
BIRAC-DBT |
| Address |
Biotechnology Industry Research Assistance Council (BIRAC)
5th Floor, NSIC Business Park, NSIC Bhawan,
Okhla Industrial Estate, New Delhi - 110020 |
| Type of Sponsor |
Government funding agency |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Charuta J Puranik |
Sujay Eye Hospital, Nanalnagar 500008 |
| NIL |
NIL |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Viswamitra |
Dr. Rednam Surya Prasadrao Government Regional Eye Hospital |
Mohsin Eye Bank Department of Ophthalmology, Cornea and Anterior Segment Division, Room no NA Waltair Cemetery, near Rama Talkies, Old TB Hospital Area, Seetamma Peta, Dwaraka Nagar, Visakhapatnam, Andhra Pradesh 530016
Visakhapatnam
ANDHRA PRADESH |
8978247708
viswamithra20@gmail.com |
| Dr Charuta J Puranik |
Oculus Regenerus Eye Care and Research Center |
Cornea and Anterior Segment Department, Division NA Room No NA Nanal Nagar, Mehdipatnam, Hyderabad, Telangana 500008
Hyderabad
TELANGANA |
7350018265
charuta.j.p17@gmail.com |
| Dr B Vijayalaxmi |
Sarojini Devi Eye Hospital |
Cornea and Anterior Segment Department, Tapadia Eye Bank Room No NA First Floor, Mehdipatnam Rd, Ex Service Men Colony, Humayun Nagar, Hyderabad, Telangana 500028
Hyderabad
TELANGANA |
8121462897
drvijju2108@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| IEC King George Hospital |
Submittted/Under Review |
| KIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
After death we will collect donor corneas from willing donors/family members |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Donor Corneoscleral Rim excision by Traditional Technique |
Traditional Technique involves the use of NO drug in the anterior chamber before the excision of the Donor rim. This is a single-time intervention that happens after the death of the deceased.
The Anterior chamber may collapse during the procedure and cause endothelial cell loss in case of improper technique |
| Comparator Agent |
Use of Viscoelastic Device intra procedure |
This is a single-time intervention done after the deceased has donated eyes. Grasping the eyeball by the limbus with toothed forceps the allocated sample ( Sodium Hyaluronate with chondroitin sulfate or sodium Hyaluronate or Hydroxypropyl methyl cellulose 2% will be injected into the anterior chamber of the donor. Subsequently excision of the corneoscleral rim will be performed similarly to the traditional technique |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
1. All Corneas Harvested from Eye Bank
2. Consecutive recruitment
3. Death to collection time less than 6 hours (with or without body cooling)
|
|
| ExclusionCriteria |
| Details |
1. Death to collection time more than 6 hours
2. Accidental injury during tissue transport
3. Improper harvesting technique
4. Vitreous loss during collection of tissue
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Endothelial Cell density on sepcular Microscopy |
1. Post Harvesting Day 1
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| No of Rejected tissues I vs II |
1. Post harvesting day 4
2. Post Harvesting Day 14 |
| Percentage Hexagonality |
1. Post Harvesting Day 1 |
| Area of cell |
1. Post Harvesting Day 1 |
| No Of Cells Counted |
1. Post Harvesting Day 1 |
| Rejected Tissues vital cell analysis |
1. Post Harvesting Day 4
2. 1. Post Harvesting Day 15 |
|
|
Target Sample Size
|
Total Sample Size="500"
Sample Size from India="500"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
30/03/2024 |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- 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 [charuta.j.p17@gmail.com].
- For how long will this data be available start date provided 01-07-2024 and end date provided 17-09-2029?
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
|
Corneal
transplantation is the most successful type of organ transplantation. Thus far
the eye donation movement in India has gained tremendous momentum owing to
widespread awareness and a major paradigm shift in public attitude. However, of
collected tissues only half are used for transplantation purposes. The
remaining are utilized for medical education or experimental research and a
large proportion of non-utilization due to multiple reasons- most often due to
poor quality. Poor
quality tissues are likely to result in primary graft failure after corneal
transplantation. It is therefore of utmost importance to protect the corneal
endothelium and improve the viability of the cells during harvesting
itself. Current techniques of harvesting
of cornea rely on skill set of the technician/resident/doctor for preventing
damage to the corneal tissues during harvesting. By this study we intend to
improve the vitality of the cells and decrease intra harvesting damage to the
corneal endothelium. This will eventually improve the Quality of tissues
harvested and decrease the wastageThe trial is step forward to improve the health of donor corneas that are harvested after death. We are using clinically proven medications that are routinely used in ophthalmic surgery, for comparing the health and cell counts by a simple modification of the existing harvesting technique. 4 eye bank centers are enrolled for the project. |