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

Recurrence Clinical Trial

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT02015000
• Other study ID #: 201306012RINC
• Status: Unknown status
• Phase: N/A
• First received: December 8, 2013
• Last updated: December 12, 2013
• Start date: November 2013
• Est. completion date: November 2014

Study information

• Verified date: December 2013
• Source: National Taiwan University Hospital
• Contact: Hsin-Yu y Liu
• Phone: 886829779756
• Email: singhuh[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 60
• Est. completion date: November 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Pterygium
• Recurrence

Intervention

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)

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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