Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Pterygium Clinical Trial

Official title:

Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00949728
• Other study ID #: cola106
• Status: Completed
• Phase: N/A
• First received: July 17, 2009
• Last updated: July 29, 2009
• Start date: October 2006
• Est. completion date: July 2009

Study information

• Verified date: July 2009
• Source: Hospital de Olhos Sadalla Amin Ghanem
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

To evaluate the recurrence and postoperative complications rates after conjunctival autograft surgery using fibrin adhesive for primary pterygium

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: July 2009
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of primary pterygium

• Symptomatic pterygium

• Limbal invasion

Exclusion Criteria:

• Secondary pterygium

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Primary
• Pterygium

Intervention

Procedure:
• Conjunctival autograft using fibrin glue
Conjunctival autograft using fibrin glue in pterygium surgery

Locations

Country	Name	City	State
Brazil	Sadalla Amin Ghanem Eye Hospital	Joinville	SC

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Olhos Sadalla Amin Ghanem

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

Bahar I, Weinberger D, Gaton DD, Avisar R. Fibrin glue versus vicryl sutures for primary conjunctival closure in pterygium surgery: long-term results. Curr Eye Res. 2007 May;32(5):399-405. — View Citation

Koranyi G, Seregard S, Kopp ED. Cut and paste: a no suture, small incision approach to pterygium surgery. Br J Ophthalmol. 2004 Jul;88(7):911-4. — View Citation

Marticorena J, Rodríguez-Ares MT, Touriño R, Mera P, Valladares MJ, Martinez-de-la-Casa JM, Benitez-del-Castillo JM. Pterygium surgery: conjunctival autograft using a fibrin adhesive. Cornea. 2006 Jan;25(1):34-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Recurrence of pterygium after its excision with the conjunctival autograft technique.		One, three and five months after surgery.	No
Secondary	Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.		One day, one week and one month after surgery.	No