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

Chulalongkorn University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pterygium

Treatments: Procedure: Amniotic membrane transplantation using fibrin glue

Study type: Interventional

Funder types: Other

Identifiers

NCT00457223

401/49

Details and patient eligibility

About

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

Full 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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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32 participants in 2 patient groups

1Fibrin glue

Experimental group

Description:

After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®)

Treatment:

Procedure: Amniotic membrane transplantation using fibrin glue

2 Suture

Active Comparator group

Description:

After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using continuous suture with nylon 10-0

Treatment:

Procedure: Amniotic membrane transplantation using fibrin glue