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CompletedNCT00457223Updated Feb 13, 2008

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

A Phase 2/3 interventional study of Amniotic membrane transplantation using fibrin glue in Pterygium, sponsored by Chulalongkorn University. Completed at 1 site in Thailand. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2008-02-13.

Sponsored by Chulalongkorn University · Phase 2/3, Interventional, and Treatment

Phase
Phase 2/3
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.
02

Conditions studied

  • Pterygium

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Keywords

  • pterygium
  • pterygia
  • excision
  • amniotic membrane transplantation
  • fibrin glue
  • suture
03

In context

Pterygium

111 studies on the registry are indexed under Pterygium; 10 are open to participants now.

This study's enrollment of 32 is below the median of 60 across 92 interventional studies indexed under Pterygium.

Browse Pterygium studies →

Lead sponsor

Chulalongkorn University is the lead sponsor of 312 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • primary pterygium

Exclusion criteria

Exclusion Criteria:

  • Pregnant women
  • Recurrent pterygium
  • Pseudopterygium
  • Uncontrolled systemic disease.
  • Known allergy to any of the study agents or preservatives used in the formulations.
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (actual)

Study arms

  • Experimental
    1Fibrin glue

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

    Procedure: Amniotic membrane transplantation using fibrin glue

  • Active comparator
    2 Suture

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

    Procedure: Amniotic membrane transplantation using fibrin glue

Interventions

  • ProcedureAmniotic 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.

    Also known as: Quixil®, Nylon 10-0

06

What researchers measure

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

07

Study locations

1 site
  • Department of Ophthalmology, King Chulalongkorn Memorial hospital
    Bangkok, 10330, Thailand
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 13, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00457223
Lead sponsor
Chulalongkorn University
First posted
Apr 6, 2007
Start date
Apr 2007
Primary completion
Aug 2007
Completion
Aug 2007
Last update
Feb 13, 2008

Study contacts

Ngamjit Kasetsuwan, MD
study chair · Ophthalmology Department, Faculty of Medicine, Chulalongkorn University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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