| CTRI Number |
CTRI/2013/06/003764 [Registered on: 18/06/2013] Trial Registered Retrospectively |
| Last Modified On: |
04/05/2019 |
| 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
|
A Clinical trial to study the effects of two techniques-using patients own blood and fibrin glue-for conjunctival graft adherence in pterygium surgery |
|
Scientific Title of Study
|
A Prospective Randomised Controlled Trial to compare the efficacy and outcome of Autologous blood and Fibrin glue for conjunctival autograft adherence in Sutureless Pterygium surgery |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| U1111-1140-6572 |
UTN |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abraham Kurian |
| Designation |
Senior Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Kesavadasapuram,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
919847094478 |
| Fax |
04712443985 |
| Email |
abrahamkurian55@yahoo.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Iodine Reghunadhan |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Kesavadasapuram,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
919847104830 |
| Fax |
04712443985 |
| Email |
iodine_b@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Iodine Reghunadhan |
| Designation |
Consultant |
| Affiliation |
Chaithanya Eye Hospital and Research Institute |
| Address |
Kesavadasapuram,
Thiruvananthapuram
Thiruvananthapuram
KERALA
695004
India |
| Phone |
919847104830 |
| Fax |
04712443985 |
| Email |
iodine_b@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Chaithanya Eye Hospital and Research Institute, Kesavadasapuram,Thiruvananthapuram |
|
|
Primary Sponsor
|
| Name |
Dr Abraham Kurian |
| Address |
Senior Consultant,
Chaithanya Eye Hospital and Research Institute, Kesavadasapuram,
Thiruvananthapuram |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Iodine Reghunadhan |
Consultant,
Chaithanya Eye Hospital and Research Institute, Kesavadasapuram,
Thiruvananthapuram |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Abraham Kurian |
Chaithanya Eye Hospital and Research Institute |
Kesavadasapuram,
Thiruvananthapuram
Thiruvananthapuram
KERALA |
919847094478
04712443985
abrahamkurian55@yahoo.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICAL COMMITTEE, CHAITHANYA EYE HOSPITAL AND RESEARCH INSTITUTE, Kesavadasapuram,Thiruvananthapuram |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Clinically Significant Primary Pterygium, (1) ICD-10 Condition: H110||Pterygium of eye, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Excision Pterygium with Free Conjunctival Autograft with Autologous blood |
Patients own blood at the surgical site is used for adherence of the conjunctival autograft to the bare scleral bed |
| Comparator Agent |
Excision Pterygium with Free Conjunctival Autograft with Fibrin glue |
Commercially available fibrin glue is used for adherence of the conjunctival autograft to the bare scleral bed |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Clinically significant primary pterygia |
|
| ExclusionCriteria |
| Details |
1)Recurrent Pterygium
2)Patients with significant ocular surface disease
3)Patients with known hypersensitivity to fibrin glue or any of its components
4)Patients on Anticoagulants or antirheological agents (as these are thought to have an adverse effect on the adherence of the graft with autologous blood) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1)Graft adherence
2)Recurrence |
1)1 day,1 week
2)1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Complications like Graft retraction,Subconjunctival haemorrhage |
1 day,1 week,1month |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="50" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/01/2012 |
| Date of Study Completion (India) |
24/03/2015 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Closed to recruitment of participants: Follow- up continuing |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This study is a randomised controlled,parallel group interventional single centre trial to compare the efficacy and outcome of Autologous blood and fibrin glue for conjunctival graft adherence in sutureless pterygium surgery, in 200 patients with primary pterygia. The patients are randomly assigned to two groups-Group I - using autologous blood and Group II - using fibrin glue.The primary outcome measures will be the graft adherence assessed at 1 day and 1 week and recurrence at 1 year postoperatively. Secondary outcome measures will be incidence of graft related complications at 1 day, 1 week and 1 month postoperatively. |