| CTRI Number |
CTRI/2014/09/005067 [Registered on: 26/09/2014] Trial Registered Retrospectively |
| Last Modified On: |
13/01/2021 |
| 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 safety and efficacy of amniotic membrane transplantation and cord blood serum in cases of acute chemical injury of the eye |
|
Scientific Title of Study
|
A Prospective Randomized Controlled Clinical Trial to Compare the Safety and Efficacy of Topical Cord Blood Serum Drops and Amniotic Membrane Transplantation in Acute Chemical Injury
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor of Ophthalmology |
| Affiliation |
Dr.R.P.Centre for Ophthalmic SCIENCES, AIIMS |
| Address |
Room number 474,Dr.Rajendra Prasad Centre for Ophthalmic Sciences,Ansari nagar,South Delhi
Room number 474,Dr.Rajendra Prasad Centre for Ophthalmic Sciences,Ansari nagar,South Delhi
South
DELHI
110029
India |
| Phone |
09810856988 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Singh |
| Designation |
Junior Resident |
| Affiliation |
Dr.R.P.Centre for Ophthalmic SCIENCES, AIIMS |
| Address |
Room number 474,Dr.Rajendra Prasad Centre for Ophthalmic Sciences,Ansari nagar,South Delhi
Room number 474,Dr.Rajendra Prasad Centre for Ophthalmic Sciences,Ansari nagar,South Delhi
South
DELHI
110029
India |
| Phone |
09868354999 |
| Fax |
|
| Email |
divyas865@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor of Ophthalmology |
| Affiliation |
Dr.R.P.Centre for Ophthalmic SCIENCES, AIIMS |
| Address |
Room number 474,Dr.Rajendra Prasad Centre for Ophthalmic Sciences,Ansari nagar,South Delhi
Room number 474,Dr.Rajendra Prasad Centre for Ophthalmic Sciences,Ansari nagar,South Delhi
South
DELHI
110029
India |
| Phone |
09810856988 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS, New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad Centre for Ophthalmic Sciences |
| Address |
All India Institute Of Medical Sciences |
| Type of Sponsor |
Government medical college |
|
|
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 Namrata Sharma |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
South
DELHI |
09810856988
namrata.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Acute Ocular Chemical Injury, (1) ICD-10 Condition: T264||Burn of eye and adnexa, part unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane Grafting |
15 patients of acute chemical injury treated with amniotic membrane grafting in adjunction to standard treatment |
| Intervention |
Cord Blood Serum adjunctive to standard treatment |
15 patients of acute chemical injury treated with cord blood serum in adjunction to standard treatment |
| Comparator Agent |
Standard Treatment |
15 patients of acute chemical injury treated with standard treatment |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
52.00 Year(s) |
| Gender |
Both |
| Details |
GRADE 3,4,5 CHEMICAL INJURY AS PER DUAS CLASSIFICATION PRESENTING WITH IN 3 WKS OF INJURIES |
|
| ExclusionCriteria |
| Details |
1. GRADE 1,2,6 CHEMICAL INJURY AS PER DUAS CLASSIFICATION PRESENTING WITH IN 3 WKS OF INJURIES
2.IMPENDING PERFORATION OR PERFORATION AT PRESENTATION
3.NOT WILLING FOR PARTICIPATION OR FOLLOW UP |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.VISUAL ACUITY
2.DUAS CLASSIFICATION
3.CORNEAL CLARITY
4.EPITHELIAL DEFECT
5.LIMBAL INVOLVEMENT |
3 MONTHS
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.PAIN SCORE
2.TEAR FILM STATUS
3.INTRAOCULAR PRESSURE
4.OTHER COMPLICATIONS |
3 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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 4 |
|
Date of First Enrollment (India)
|
18/06/2013 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
PURPOSE: A PROSPECTIVE RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE SAFETY AND EFFICACY OF TOPICAL CORD BLOOD SERUM DROPS AND AMNIOTIC MEMBRANE TRANSPLANTATION IN ACUTE CHEMICAL INJURYDESIGN: RANDOMIZED, CONTROLLED, CLINICAL TRIAL
PARTICIPANTS AND CONTROLS: PARTICIPANTS WITH ACUTE CHEMICAL INJURY WERE RANDOMIZED INTO 3 GROUPS
INTERVENTION: GROUP 1 TREATED WITH STANDARD TREATMENT, GROUP 2 WITH AMNIOTIC MEMBRANE GRAFT IN ADJUNCTION TO STANDARD TREATMENT, GROUP 3 TREATED WITH CORD BLOOD SERUM IN ADJUNTION TO STANDARD TREATMENT
MAIN OUTCOME MEASURES: VISUAL ACUITY, DUA’S CLASSIFICATION, CORNEAL CLARITY, LIMBAL INVOLVEMENT, EPITHELIAL DEFECT, PAIN SCORE, TEAR FILM STATUS, INTRAOCULAR PRESSURE, OTHER COMPLICATIONS |