Surgical Result of Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation

Not Applicable

• Conditions: Pterygium; Recurrence
• Interventions: Procedure: P.E.R.F.A.M.T

• Registration Number: NCT02015000
• Lead Sponsor: National Taiwan University Hospital

Brief Summary

The treatment of pterygium is still quite controversial. Previous studies using a large incision for pterygium excision and a large graft and has reported a very low recurrence rate with the P.E.R.F.E.C.T. technique. However, the P.E.R.F.E.C.T. technique is a relatively lengthy procedure and may not be suitable for patient with limited conjunctival reserve. Thus, we try to evaluate the final outcome of a sutureless amniotic membrane transplant technique combining the extended pterygium excision in hope to avoid the complication of the P.E.R.F.E.C.T. for PTERYGIUM technique.

Detailed Description

The treatment of pterygium is still quite controversial. There is a lack of consensus in the ophthalmological community about the optimal surgical management of pterygia. The main challenge to successful surgical treatment of pterygium is recurrence, evidenced by fibrovascular growth across the limbus onto the cornea.

Previous studies using a large incision for pterygium excision and a large graft and has reported a very low recurrence rate with the P.E.R.F.E.C.T. technique. However, the P.E.R.F.E.C.T. for PTERYGIUM technique is not that perfect since it is a lengthy procedure, requires meticulous handling of tissue, and is associated with significant postoperative pain and, frequently, transient diplopia. Therefore, we try to evaluate the final outcome of a sutureless amniotic membrane transplant technique combining the extended pterygium excision in hope to avoid the complication of the P.E.R.F.E.C.T. for PTERYGIUM technique. This sutureless technique with the tissue glue may promote increased clinical use of amniotic membrane patch by alleviating patients' pain and shortening surgical time.

Study Timeline

• Study Start: 2013-11
• Status Verified: 2013-12
• Primary Completion: 2013-12
• Study First Submitted: 2013-12-08
• Study First Submitted QC: 2013-12-12
• Last Update Submitted: 2013-12-12
• Study First Posted: 2013-12-19
• Last Update Posted: 2013-12-19
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patient with pterygium
• Operated by single surgeon (Chen, Wei-Li)

Exclusion Criteria

• Follow-up time less than 12 months
• Age less then 18 year-old

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pterygium recurrence	P.E.R.F.A.M.T	Surgical Result of Primary and Recurrent Pterygium by Using Pterygium Extended Removal followed by Fibrin Glue Assisted Amniotic Membrane Transplantation (P.E.R.F.A.M.T)

Primary Outcome Measures

Name	Time	Method
Recurrence of pterygium	1 year	defined as proliferating conjunctival tissue was found extending the limbus more than 1 mm onto the cornea within the surgical field )

Secondary Outcome Measures

Name	Time	Method
caruncular morphology	1 year	A grading scale of 1 to 4 for the caruncle morphological characteristics was designed. Grade 1 with a normal appearance of the operated site; Grade 2 with the presence of fine episcleral vessels in the excised area, extending to the limbus, but without any fibrous tissue; Grade 3 with fibrovascular tissue in the excised area, reaching to the limbus but not invading the cornea; Grade 4 with aA true corneal recurrence, with fibrovascular tissue invading the cornea and across the limbus.

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taipei City, Taiwan