To Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Phase 2

Completed

• Conditions: Pterygium
• Interventions: Procedure: Amniotic membrane transplantation using fibrin glue

• Registration Number: NCT00457223
• Lead Sponsor: Chulalongkorn University

Brief Summary

The purpose of this study is to compared between conventional pterygium excision and AMT transplantation with suture and with fibrin glue.

Detailed Description

There are few studies about use of fibrin glue in pterygium surgery with conjunctival auto-graft with promising outcome. Less recurrent rate, less discomfort and halve surgical time were reported.

Up to our knowledge,there is no report of fibrin glue in pterygium excision with amniotic membrane transplantation(AMT). There is conventional technique to use AMT in King Chulalongkorn Memorial Hospital because some benefits over conjunctival auto-graft e.g.

* Preserve healthy superior conjunctiva for future glaucoma filtering surgery

* Can use in big or 2-headed pterygium

* Not contract as conjunctival graft esp. in case of fibrin glue

* Potential easier to use with fibrin glue

* Available from Thai Red Cross Eye Bank Comparison(s): amniotic membrane transplantation using fibrin glue compare to suture after pterygium excision.

Study Timeline

• Study Start: 2007-04
• Study First Submitted: 2007-04-04
• Study First Submitted QC: 2007-04-04
• Study First Posted: 2007-04-06
• Primary Completion: 2007-08
• Study Completion: 2007-08
• Status Verified: 2008-02
• Last Update Submitted: 2008-02-12
• Last Update Posted: 2008-02-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

• primary pterygium

Exclusion Criteria

• Pregnant women
• Recurrent pterygium
• Pseudopterygium
• Uncontrolled systemic disease.
• Known allergy to any of the study agents or preservatives used in the formulations.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1Fibrin glue	Amniotic membrane transplantation using fibrin glue	After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®)
2 Suture	Amniotic membrane transplantation using fibrin glue	After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0

Primary Outcome Measures

Name	Time	Method
Pain and discomfort during and after surgery using visual analog scale	during surgery and after surgery up to 30 days

Secondary Outcome Measures

Name	Time	Method
Surgical time	start and to the end of surgery
Healing of epithelial defect on cornea and AMT	until 30 days
Postoperative inflammation	up to 30 days
Complications e.g. Recurrent, graft loss/dehiscent, re-operation	until last follow up

Trial Locations

Locations (1)

Department of Ophthalmology, King Chulalongkorn Memorial hospital; 🇹🇭 Bangkok, Thailand