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

National Taiwan University

Status: Unknown

Conditions: Pterygium; Recurrence

Treatments: Procedure: P.E.R.F.A.M.T

Study type: Interventional

Funder types: Other

Identifiers

NCT02015000

201306012RINC

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

60 participants in 1 patient group

pterygium recurrence

Experimental group

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)

Treatment:

Procedure: P.E.R.F.A.M.T