NCT00949728

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
151

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2006

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2006

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 17, 2009

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 30, 2009

Completed
Last Updated

July 30, 2009

Status Verified

July 1, 2009

Enrollment Period

1.8 years

First QC Date

July 17, 2009

Last Update Submit

July 29, 2009

Conditions

Keywords

PterygiumAutologous TransplantationConjunctivaFibrin Tissue AdhesiveRecurrence

Outcome Measures

Primary Outcomes (1)

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

    One, three and five months after surgery.

Secondary Outcomes (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.

Study Arms (1)

Fibrin glue

OTHER
Procedure: Conjunctival autograft using fibrin glue

Interventions

Conjunctival autograft using fibrin glue in pterygium surgery

Also known as: Pterygium surgery using fibrin glue
Fibrin glue

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Secondary pterygium

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sadalla Amin Ghanem Eye Hospital

Joinville, Santa Catarina, 89201-010, Brazil

Location

Related Publications (3)

  • 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.

    PMID: 15205236BACKGROUND
  • 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.

    PMID: 17514524BACKGROUND
  • 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.

    PMID: 16331038BACKGROUND

MeSH Terms

Conditions

PterygiumRecurrence

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Renan F Oliveira

    PRINCIPAL INVESTIGATOR
  • Ramon C Ghanem, M.D.

    Sadalla Amin Ghanem Eye Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 17, 2009

First Posted

July 30, 2009

Study Start

October 1, 2006

Primary Completion

August 1, 2008

Study Completion

July 1, 2009

Last Updated

July 30, 2009

Record last verified: 2009-07

Locations