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A Clinical trial to study the effects of two techniques-using patients own blood and fibrin glue-for conjunctival graft adherence in pterygium surgery

Completed
Conditions
Pterygium of eye,
Registration Number
CTRI/2013/06/003764
Lead Sponsor
Dr Abraham Kurian
Brief Summary

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.

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
All
Target Recruitment
200
Inclusion Criteria

Clinically significant primary pterygia.

Exclusion Criteria

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).

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
2)Recurrence1)1 day,1 week | 2)1 year
1)Graft adherence1)1 day,1 week | 2)1 year
Secondary Outcome Measures
NameTimeMethod
Complications like Graft retraction,Subconjunctival haemorrhage1 day,1 week,1month

Trial Locations

Locations (1)

Chaithanya Eye Hospital and Research Institute

🇮🇳

Thiruvananthapuram, KERALA, India

Chaithanya Eye Hospital and Research Institute
🇮🇳Thiruvananthapuram, KERALA, India
Dr Abraham Kurian
Principal investigator
919847094478
abrahamkurian55@yahoo.in

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