NCT00383825

Brief Summary

To evaluate graft vascularization and compare the vascularization patterns of conjunctival autografts with amniotic membrane grafts to better understand the factors involved in pterygium recurrence.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2003

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

January 1, 2003

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 4, 2006

Completed
Last Updated

October 4, 2006

Status Verified

October 1, 2006

First QC Date

October 2, 2006

Last Update Submit

October 2, 2006

Conditions

Pterygium

Keywords

conjunctival autograftsamniotic membraneindocyanine green angiographypterygium surgery

Outcome Measures

Primary Outcomes (4)

  • After intravenous injection of ICG dye, photographs were taken at approximately 1- to 2-second intervals until the first appearance of the dye, and then at 10-second intervals for the next 4 minutes.

  • Thereafter, photographs were captured at 5, 10, and 20 minutes.

  • ICGA results of all patients were evaluated at monthly intervals after surgery.

  • Showing the re-vascularization during the follow-up period was the primary measure.

Interventions

Anterior segment indocyanine green angiographyPROCEDURE

Eligibility Criteria

Age0 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who had primary pterygium

You may not qualify if:

  • Patients with major systemic diseases (eg, diabetes), vascular disease (excluding hypertension), serious ocular surface disease (eg, cicatricial pemphigoid), glaucoma and previous history of ocular surgery
  • Patients with pterygia of both eyes

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baskent University Hospital Department of Ophthalmology

Ankara, 06490, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pterygium

Condition Hierarchy (Ancestors)

Conjunctival DiseasesEye Diseases

Study Officials

  • Yonca A Akova, Md

    Bakent University Faculty of Medicine Department of Ophthalmology

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 2, 2006

First Posted

October 4, 2006

Study Start

January 1, 2003

Study Completion

December 1, 2004

Last Updated

October 4, 2006

Record last verified: 2006-10

Locations

TU(1)