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

Pterygium Clinical Trial

Official title:

Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00457223
• Other study ID #: 401/49
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 4, 2007
• Last updated: February 12, 2008
• Start date: April 2007
• Est. completion date: August 2007

Study information

• Verified date: February 2008
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: August 2007
• Est. primary completion date: August 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pterygium

Intervention

Procedure:
• Amniotic membrane transplantation using fibrin glue
After pterygium excision, amniotic membrane was shaped and attached to bare scleral area using fibrin glue (Quixil®) in 16 eyes of 16 patients of FG group and continuous suture with nylon 10-0 in 16 eyes of 16 patients of SU group.

Locations

Country	Name	City	State
Thailand	Department of Ophthalmology, King Chulalongkorn Memorial hospital	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain and discomfort during and after surgery using visual analog scale		during surgery and after surgery up to 30 days	No
Secondary	Surgical time		start and to the end of surgery	No
Secondary	Healing of epithelial defect on cornea and AMT		until 30 days	No
Secondary	Postoperative inflammation		up to 30 days	Yes
Secondary	Complications e.g. Recurrent, graft loss/dehiscent, re-operation		until last follow up	Yes