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Completed

NCT Number: NCT00457223

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

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

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Department of Ophthalmology, King Chulalongkorn Memorial hospital

Bangkok, 10330, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Amniotic membrane transplantation using fibrin glue

Procedure

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.

Other names: Quixil®, Nylon 10-0

Primary outcomes

  1. Pain and discomfort during and after surgery using visual analog scale

    Time frame: during surgery and after surgery up to 30 days

Secondary outcomes

  1. Surgical time

    Time frame: start and to the end of surgery

  2. Healing of epithelial defect on cornea and AMT

    Time frame: until 30 days

  3. Postoperative inflammation

    Time frame: up to 30 days

  4. Complications e.g. Recurrent, graft loss/dehiscent, re-operation

    Time frame: until last follow up

Sponsors and collaborators

Lead sponsor

Chulalongkorn University

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Apr 6, 2007
Registry last updated
Feb 13, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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