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Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

Primary Purpose

Pterygium, Primary

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Conjunctival autograft using fibrin glue
Sponsored by
Hospital de Olhos Sadalla Amin Ghanem
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pterygium focused on measuring Pterygium, Autologous Transplantation, Conjunctiva, Fibrin Tissue Adhesive, Recurrence

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Clinical diagnosis of primary pterygium
  • Symptomatic pterygium
  • Limbal invasion

Exclusion Criteria:

  • Secondary pterygium

Sites / Locations

  • Sadalla Amin Ghanem Eye Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Fibrin glue

Arm Description

Outcomes

Primary Outcome Measures

Recurrence of pterygium after its excision with the conjunctival autograft technique.

Secondary Outcome Measures

Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.

Full Information

First Posted
July 17, 2009
Last Updated
July 29, 2009
Sponsor
Hospital de Olhos Sadalla Amin Ghanem
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1. Study Identification

Unique Protocol Identification Number
NCT00949728
Brief Title
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
Official Title
Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
October 2006 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
July 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital de Olhos Sadalla Amin Ghanem

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium, Primary
Keywords
Pterygium, Autologous Transplantation, Conjunctiva, Fibrin Tissue Adhesive, Recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
151 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fibrin glue
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Conjunctival autograft using fibrin glue
Other Intervention Name(s)
Pterygium surgery using fibrin glue
Intervention Description
Conjunctival autograft using fibrin glue in pterygium surgery
Primary Outcome Measure Information:
Title
Recurrence of pterygium after its excision with the conjunctival autograft technique.
Time Frame
One, three and five months after surgery.
Secondary Outcome Measure Information:
Title
Postoperative complications following the pterygium excision, such as partial graft detachment, dellen, granuloma or sutures failure.
Time Frame
One day, one week and one month after surgery.

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Clinical diagnosis of primary pterygium Symptomatic pterygium Limbal invasion Exclusion Criteria: Secondary pterygium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renan F Oliveira
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ramon C Ghanem, M.D.
Organizational Affiliation
Sadalla Amin Ghanem Eye Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Sadalla Amin Ghanem Eye Hospital
City
Joinville
State/Province
SC
ZIP/Postal Code
89201-010
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15205236
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. doi: 10.1136/bjo.2003.032854.
Results Reference
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PubMed Identifier
17514524
Citation
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. doi: 10.1080/02713680701294723.
Results Reference
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PubMed Identifier
16331038
Citation
Marticorena J, Rodriguez-Ares MT, Tourino 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. doi: 10.1097/01.ico.0000164780.25914.0a.
Results Reference
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Conjunctival Autologous Transplantation Using Fibrin Glue in Primary Pterygia

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