| CTRI Number |
CTRI/2015/07/005960 [Registered on: 03/07/2015] Trial Registered Retrospectively |
| Last Modified On: |
13/07/2015 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare which type of sugery is better for treatment of pterygium |
Scientific Title of Study
Modification(s)
|
Comparative outcome of Conjunctival autograft and Amniotic membrane transplantation following double pterygium excision in the same eye |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Venkatesh Prajna |
| Designation |
Chief ,Cornea services |
| Affiliation |
Aravind eye hospital |
| Address |
1,Anna Nagar,Aravind eye hospital,Madurai,Tamil Nadu,India
1,Anna nagar,Aravind eye hospital.
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356550 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Venkatesh Prajna |
| Designation |
Chief ,Cornea services |
| Affiliation |
Aravind eye hospital |
| Address |
1,Anna Nagar,Aravind eye hospital,Madurai,Tamil Nadu,India
1,Anna nagar,Aravind eye hospital.
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356550 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
Details of Contact Person
Public Query
|
| Name |
Venkatesh Prajna |
| Designation |
Chief ,Cornea services |
| Affiliation |
Aravind eye hospital |
| Address |
1,Anna Nagar,Aravind eye hospital,Madurai,Tamil Nadu,India
1,Anna nagar,Aravind eye hospital.
Madurai
TAMIL NADU
625020
India |
| Phone |
04524356550 |
| Fax |
914522530984 |
| Email |
prajna@aravind.org |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Aravind Eye care System |
| Address |
1,Anna Nagar,Aravind eye hospial.Madurai-625020 Tamilnadu |
| 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 |
| Venkatesh Prajna |
Aravind Eye Hospital |
Room no 314,3rd floor, Cornea services.
Madurai
TAMIL NADU |
04524356550
914522530984
prajna@aravind.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Aravind eye care system intitutional review board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Double pterygium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
amniotic membrane graft |
Tissue which is prepared from human placenta and processed and preserved placed at the excision site.Since this is not a drug there is no dosage schedule and its done only once. |
| Comparator Agent |
conjunctival autograft |
The tissue which is taken from patients own superior bulbar conjunctiva and tranplanted at the excised site |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
age more than 18 years
primary double pterygium with operable features |
|
| ExclusionCriteria |
| Details |
children below the age of 18 years
previous history of trauma or chemical injury
pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the recuurence of pterygium nasally and temporally after double pterygium excision when replaced with conjunctival autograft and amniotic graft randomly |
0-1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess whether site of replacement of the conjunctival autograft and amniotic membrane graft plays a role in recurrence |
0-1 year |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
05/04/2011 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study is a randomized control trial to compare the recurrence rate following double pterygium excision in the same eye after replacement at the excised site with conjunctival autograft and amniotic membrane graft. This study concluded that conjunctival autograft is superior to amniotic membrane graft as a tissue replacement following pterygium surgery irrespective of site of transplantation.
|