Clinical trial NCT02015000: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Pterygium
Recurrence
Keywords: Pterygium
Recurrence
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2013-12-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Recurrence of pterygium
timeFrame: 1 year
Secondary outcomes:
measure: caruncular morphology
timeFrame: 1 year
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
state: Taipei City
Study officials:
affiliation: National Taiwan University Hospital
name: Wei-Li Chen
role: STUDY_DIRECTOR
References:
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.
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.