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

This study has been completed.
Sponsor:
Information provided by:
Baskent University
ClinicalTrials.gov Identifier:
NCT00383825
First received: October 2, 2006
Last updated: NA
Last verified: October 2006
History: No changes posted
  Purpose

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.


Condition Intervention
Pterygium
Procedure: Anterior segment indocyanine green angiography

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Screening
Official Title: Interventional Study of Vascularization Detected by ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision

Resource links provided by NLM:


Further study details as provided by Baskent University:

Primary Outcome Measures:
  • 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.

Estimated Enrollment: 30
Study Start Date: January 2003
Estimated Study Completion Date: December 2004
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00383825

Locations
Turkey
Baskent University Hospital Department of Ophthalmology
Ankara, Turkey, 06490
Sponsors and Collaborators
Baskent University
Investigators
Study Director: Yonca A Akova, Md Bakent University Faculty of Medicine Department of Ophthalmology
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00383825     History of Changes
Other Study ID Numbers: B02-123456-2
Study First Received: October 2, 2006
Last Updated: October 2, 2006
Health Authority: Turkey: Ministry of Health

Keywords provided by Baskent University:
conjunctival autografts
amniotic membrane
indocyanine green angiography
pterygium surgery

Additional relevant MeSH terms:
Pterygium
Conjunctival Diseases
Eye Diseases

ClinicalTrials.gov processed this record on October 19, 2014