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

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

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00457223

Enrollment

Registered

2007-04-06

Start date

2007-04-30

Completion date

2007-08-31

Last updated

2008-02-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pterygium

Keywords

pterygium, pterygia, excision, amniotic membrane transplantation, fibrin glue, suture

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.

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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame
Pain and discomfort during and after surgery using visual analog scale	during surgery and after surgery up to 30 days

Secondary

Measure	Time frame
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

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026