Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

• Sponsor: Hospital de Olhos Sadalla Amin Ghanem (Other)
• Overall Status: Completed
• CT.gov ID: NCT00949728
• Collaborator: (none)
• Enrollment: 151
• Location: 1
• Arm: 1
• Duration (Months): 33
• Patients Per Site Per Month: 4.6

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Pterygium; Primary	Procedure: Conjunctival autograft using fibrin glue	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 151 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
• Study Start Date: Oct 1, 2006
• Actual Primary Completion Date: Aug 1, 2008
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Other: Fibrin glue	Procedure: Conjunctival autograft using fibrin glue; Conjunctival autograft using fibrin glue in pterygium surgery; Other Names: Pterygium surgery using fibrin glue

Outcome Measures

Primary Outcome Measures

1. Recurrence of pterygium after its excision with the conjunctival autograft technique. [One, three and five months after surgery.]

Secondary Outcome Measures

1. 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.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Clinical diagnosis of primary pterygium

• Symptomatic pterygium

• Limbal invasion

Exclusion Criteria:

• Secondary pterygium

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sadalla Amin Ghanem Eye Hospital	Joinville	SC	Brazil	89201-010

Sponsors and Collaborators

• Hospital de Olhos Sadalla Amin Ghanem

Investigators

• Principal Investigator: Renan F Oliveira,
• Study Director: Ramon C Ghanem, M.D., Sadalla Amin Ghanem Eye Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00949728
• Other Study ID Numbers: cola106
• First Posted: Jul 30, 2009
• Last Update Posted: Jul 30, 2009
• Last Verified: Jul 1, 2009

• Keywords provided by , ,: Pterygium; Autologous Transplantation; Conjunctiva; Fibrin Tissue Adhesive; Recurrence
• Additional relevant MeSH terms: Pterygium; Fibrin Tissue Adhesive

Study Results

No Results Posted as of Jul 30, 2009