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

NCT ID: NCT00457223

Last Updated: 2008-02-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-04-30

Study Completion Date

2007-08-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Pterygium

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1Fibrin glue

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

Group Type EXPERIMENTAL

Amniotic membrane transplantation using fibrin glue

Intervention Type 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.

2 Suture

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

Group Type ACTIVE_COMPARATOR

Amniotic membrane transplantation using fibrin glue

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Quixil® Nylon 10-0

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Chulalongkorn University

OTHER

Sponsor Role lead

Responsible Party

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Chulalongkorn University, Faculty of Medicine

Principal Investigators

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Ngamjit Kasetsuwan, MD

Role: STUDY_CHAIR

Ophthalmology Department, Faculty of Medicine, Chulalongkorn University

Locations

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Department of Ophthalmology, King Chulalongkorn Memorial hospital

Bangkok, , Thailand

Site Status

Countries

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Thailand

Other Identifiers

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401/49

Identifier Type: -

Identifier Source: org_study_id

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