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

NCT02015000 | Unknown

• 1 other identifier: 201306012RINC
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Pterygium; Recurrence

Keywords

Pterygium; Recurrence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• caruncular morphology

  1 year

Study Arms (1)

pterygium recurrence

EXPERIMENTAL

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

Interventions

P.E.R.F.A.M.T PROCEDURE

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)

pterygium recurrence

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient with pterygium
• Operated by single surgeon (Chen, Wei-Li)

You may not qualify if:

• Follow-up time less than 12 months
• Age less then 18 year-old

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei, Taipei City, 100, Taiwan

RECRUITING

Related 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.

  PMID: 18555531 BACKGROUND

• 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.

  PMID: 19576496 BACKGROUND

MeSH Terms

Conditions

Pterygium; Recurrence

Condition Hierarchy (Ancestors)

Conjunctival Diseases; Eye Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Wei-Li Chen

  National Taiwan University Hospital

  STUDY DIRECTOR

Central Study Contacts

Hsin-Yu y Liu

CONTACT

886829779756; singhuh@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2013
• First Posted: December 19, 2013
• Study Start: November 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: November 1, 2014
• Last Updated: December 19, 2013

Record last verified: 2013-12

Locations

TW (1)