NCT00457223

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Apr 2007

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 4, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 6, 2007

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2007

Completed
Last Updated

February 13, 2008

Status Verified

February 1, 2008

Enrollment Period

4 months

First QC Date

April 4, 2007

Last Update Submit

February 12, 2008

Conditions

Pterygium

Keywords

pterygiumpterygiaexcisionamniotic membrane transplantationfibrin gluesuture

Outcome Measures

Primary Outcomes (1)

  • Pain and discomfort during and after surgery using visual analog scale

    during surgery and after surgery up to 30 days

Secondary Outcomes (4)

  • 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

Study Arms (2)

1Fibrin glue

EXPERIMENTAL

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

Procedure: Amniotic membrane transplantation using fibrin glue

2 Suture

ACTIVE COMPARATOR

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

Amniotic membrane transplantation using fibrin gluePROCEDURE

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
1Fibrin glue2 Suture

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • primary pterygium

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Ophthalmology, King Chulalongkorn Memorial hospital

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Ngamjit Kasetsuwan, MD

    Ophthalmology Department, Faculty of Medicine, Chulalongkorn University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 4, 2007

First Posted

April 6, 2007

Study Start

April 1, 2007

Primary Completion

August 1, 2007

Study Completion

August 1, 2007

Last Updated

February 13, 2008

Record last verified: 2008-02

Locations

TH(1)