ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision

October 2, 2006 updated by: Baskent University

Interventional Study of Vascularization Detected by ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The vascularization and perfusion of conjunctival autografts and amniotic membrane grafts after surgery may have significance in terms of pterygium recurrence and progression. Fluorescein angiography of the anterior ocular segment has been used to evaluate ocular inflammation in scleral inflammation. However, when fluorescein is used, the quality of the angiograms is limited by rapid extravasation of the dye due to diffusion through the fenestrated capillaries of the conjunctiva and episclera. Because fluorescein has a low molecular weight and is not a protein bound molecule, patchy leakage during the first transit of the dye, which obscures the angiographic details even before the late phases of the angiogram, can be seen.

In contrast, indocyanine green (ICG) is a larger molecule than fluorescein and is more highly found in protein bound form. Therefore, it remains within the fenestrated vessels and shows negligible extravasation, which makes it ideal for use in anterior segment angiography.

Tan and coworkers have shown that the morphology of pterygium recurrence inevitably reflects a high degree of vascularity.

In this prospective study, we evaluated the anterior segment indocyanine green angiography (ICGA) findings for graft vascularization after primary pterygium excision with LCAT or AMT.

Study Type

Interventional

Enrollment

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Ankara, Turkey, 06490
        • Baskent University Hospital Department of Ophthalmology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 second and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients who had primary pterygium

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baskent University

Investigators

  • Study Director: Yonca A Akova, Md, Bakent University Faculty of Medicine Department of Ophthalmology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2003

Study Completion

December 1, 2004

Study Registration Dates

First Submitted

October 2, 2006

First Submitted That Met QC Criteria

October 2, 2006

First Posted (Estimate)

October 4, 2006

Study Record Updates

Last Update Posted (Estimate)

October 4, 2006

Last Update Submitted That Met QC Criteria

October 2, 2006

Last Verified

October 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B02-123456-2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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