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

Primary Purpose

Pterygium, Recurrence

Status
Unknown status
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
P.E.R.F.A.M.T
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium, Recurrence

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • National Taiwan University HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

pterygium recurrence

Arm Description

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)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
December 8, 2013
Last Updated
December 12, 2013
Sponsor
National Taiwan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02015000
Brief Title
Surgical Result of Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation
Official Title
Surgical Result of Primary/Recurrent Pterygium by Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
November 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Recurrence
Keywords
Pterygium, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pterygium recurrence
Arm Type
Experimental
Arm Description
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)
Intervention Type
Procedure
Intervention Name(s)
P.E.R.F.A.M.T
Intervention Description
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 Measure Information:
Title
Recurrence of pterygium
Description
defined as proliferating conjunctival tissue was found extending the limbus more than 1 mm onto the cornea within the surgical field )
Time Frame
1 year
Secondary Outcome Measure Information:
Title
caruncular morphology
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsin-Yu y Liu
Phone
886829779756
Email
singhuh@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei-Li Chen
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
National Taiwan University Hospital
City
Taipei
State/Province
Taipei City
ZIP/Postal Code
100
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsin-Yu Liu
Phone
886928779756
Email
singhuh@gmail.com
First Name & Middle Initial & Last Name & Degree
Hsin-Yu Liu

12. IPD Sharing Statement

Citations:
PubMed Identifier
18555531
Citation
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.
Results Reference
background
PubMed Identifier
19576496
Citation
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.
Results Reference
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Surgical Result of Pterygium Extended Removal Followed by Fibrin Glue Assisted Amniotic Membrane Transplantation

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