| CTRI Number |
CTRI/2009/091/001018 [Registered on: 17/12/2009] |
| Last Modified On: |
|
| Post Graduate Thesis |
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| Type of Trial |
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Type of Study
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| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A clinical trial to study the role of amniotic membrane in patients with chemical or thermal injury to the eye |
|
Scientific Title of Study
|
Amniotic Membrane Transplantation in Acute Ocular Burns: a randomized controlled clinical trial
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| Trial Acronym |
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Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Radhika Tandon |
| Designation |
|
| Affiliation |
|
| Address |
Room no. 475, 4th floor
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126588626 |
| Fax |
01126588626 |
| Email |
radhika_tan@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Radhika Tandon |
| Designation |
|
| Affiliation |
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS |
| Address |
Room no. 475, 4th floor
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126588626 |
| Fax |
01126588626 |
| Email |
radhika_tan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Radhika Tandon |
| Designation |
|
| Affiliation |
|
| Address |
Room no. 475, 4th floor
Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS
New Delhi
DELHI
110029
India |
| Phone |
01126588626 |
| Fax |
01126588626 |
| Email |
radhika_tan@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Indian Council of Medical Research |
|
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Primary Sponsor
|
| Name |
Indian Council of Medical Research |
| Address |
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| Type of Sponsor |
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Details of Secondary Sponsor
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Countries of Recruitment
|
India |
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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 for Ophthalmic Sciences |
AIIMS,-110029
New Delhi
DELHI |
91-11-26588626
91-11-26588626
radhika_tan@yahoo.com |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee, AIIMS |
Approved |
|
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Acute Ocular burns, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Amniotic Membrane transplantation |
|
| Comparator Agent |
Standard Medical therapy for ocular burns |
|
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Inclusion Criteria
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| Age From |
|
| Age To |
|
| Gender |
|
| Details |
Moderate and severe acute ocular burns |
|
| ExclusionCriteria |
| Details |
Mild ocular burns, Patients who refused consent and were not available for follow up |
|
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Method of Generating Random Sequence
|
Stratified randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| Rate of healing of corneal epithelial defect, |
day 1, day 7, weekly until 1 month, biweekly until 3 months, and monthly thereafter. |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| visual acuity, extent of corneal vascularization, corneal clarity and formation of symblepharon. |
day 1, day 7, weekly until 1 month, biweekly until 3 months, and monthly thereafter. |
|
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Target Sample Size
|
Total Sample Size="100"
Sample Size from India=""
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
N/A |
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Date of First Enrollment (India)
|
Date Missing |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/10/2002 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
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Recruitment Status of Trial (Global)
|
Completed |
| Recruitment Status of Trial (India) |
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Publication Details
|
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
This study was a prospective, randomized, controlled clinical trial to compare the efficacy of amniotic membrane transplantation in addition to standard medical therapy in patients with acute chemical or thermal ocular injury in terms of rate of healing of corneal epithelial defect, visual acuity, extent of corneal vascularization, corneal clarity and formation of symblepharon.
We found that amniotic membrane transplantation in eyes with moderate ocular burns promotes faster healing of epithelial defect in patients with moderate grade burns. |