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

This study has been completed.
Sponsor:
Information provided by:
Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT00457223
First received: April 4, 2007
Last updated: February 12, 2008
Last verified: February 2008
  Purpose

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


Condition Intervention Phase
Pterygium
Procedure: Amniotic membrane transplantation using fibrin glue
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial to Compare Fibrin Glue and Suture in Primary Pterygium Excision With Amniotic Membrane Transplantation

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • Pain and discomfort during and after surgery using visual analog scale [ Time Frame: during surgery and after surgery up to 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Surgical time [ Time Frame: start and to the end of surgery ] [ Designated as safety issue: No ]
  • Healing of epithelial defect on cornea and AMT [ Time Frame: until 30 days ] [ Designated as safety issue: No ]
  • Postoperative inflammation [ Time Frame: up to 30 days ] [ Designated as safety issue: Yes ]
  • Complications e.g. Recurrent, graft loss/dehiscent, re-operation [ Time Frame: until last follow up ] [ Designated as safety issue: Yes ]

Enrollment: 32
Study Start Date: April 2007
Study Completion Date: August 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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
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

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.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00457223

Locations
Thailand
Department of Ophthalmology, King Chulalongkorn Memorial hospital
Bangkok, Thailand, 10330
Sponsors and Collaborators
Chulalongkorn University
Investigators
Study Chair: Ngamjit Kasetsuwan, MD Ophthalmology Department, Faculty of Medicine, Chulalongkorn University
  More Information

No publications provided

Responsible Party: Ratchadapiseksompotch Fund, Chulalongkorn University, Faculty of Medicine
ClinicalTrials.gov Identifier: NCT00457223     History of Changes
Other Study ID Numbers: 401/49
Study First Received: April 4, 2007
Last Updated: February 12, 2008
Health Authority: Thailand: Ethical Committee

Keywords provided by Chulalongkorn University:
pterygium
pterygia
excision
amniotic membrane transplantation
fibrin glue
suture

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 18, 2014