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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00457223
Other study ID # 401/49
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received April 4, 2007
Last updated February 12, 2008
Start date April 2007
Est. completion date August 2007

Study information

Verified date February 2008
Source Chulalongkorn University
Contact n/a
Is FDA regulated No
Health authority Thailand: Ethical Committee
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 32
Est. completion date August 2007
Est. primary completion date August 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
Thailand Department of Ophthalmology, King Chulalongkorn Memorial hospital Bangkok

Sponsors (1)

Lead Sponsor Collaborator
Chulalongkorn University

Country where clinical trial is conducted

Thailand, 

Outcome

Type Measure Description Time frame Safety issue
Primary Pain and discomfort during and after surgery using visual analog scale during surgery and after surgery up to 30 days No
Secondary Surgical time start and to the end of surgery No
Secondary Healing of epithelial defect on cornea and AMT until 30 days No
Secondary Postoperative inflammation up to 30 days Yes
Secondary Complications e.g. Recurrent, graft loss/dehiscent, re-operation until last follow up Yes
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