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

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

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.

Study Overview

• Status: Unknown
• Conditions: Recurrence; Pterygium
• Intervention / Treatment: Procedure: P.E.R.F.A.M.T

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei City
    • Taipei, Taipei City, Taiwan, 100
      • Recruiting
      • National Taiwan University Hospital
      • Contact: Hsin-Yu Liu; Phone Number: 886928779756; Email: singhuh@gmail.com
      • Sub-Investigator: Hsin-Yu Liu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: pterygium recurrence; 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)	Procedure: 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)

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
caruncular morphology	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.	1 year

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital
• Investigators: Study Director: Wei-Li Chen, National Taiwan University Hospital

Publications and helpful links

General Publications

• Hirst LW. Prospective study of primary pterygium surgery using pterygium extended removal followed by extended conjunctival transplantation. Ophthalmology. 2008 Oct;115(10):1663-72. doi: 10.1016/j.ophtha.2008.03.012. Epub 2008 Jun 16.
• Hirst LW. Recurrent pterygium surgery using pterygium extended removal followed by extended conjunctival transplant: recurrence rate and cosmesis. Ophthalmology. 2009 Jul;116(7):1278-86. doi: 10.1016/j.ophtha.2009.01.044.

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (ANTICIPATED): December 1, 2013
• Study Completion (ANTICIPATED): November 1, 2014

Study Registration Dates

• First Submitted: December 8, 2013
• First Submitted That Met QC Criteria: December 12, 2013
• First Posted (ESTIMATE): December 19, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): December 19, 2013
• Last Update Submitted That Met QC Criteria: December 12, 2013
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Recurrence; Pterygium
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Conjunctival Diseases; Recurrence; Pterygium
• Other Study ID Numbers: 201306012RINC