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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00383825
Recruitment Status : Completed
First Posted : October 4, 2006
Last Update Posted : October 4, 2006
Information provided by:
Baskent University

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.

Condition or disease Intervention/treatment Phase
Pterygium Procedure: Anterior segment indocyanine green angiography Not Applicable

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  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Screening
Official Title: Interventional Study of Vascularization Detected by ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision
Study Start Date : January 2003
Study Completion Date : December 2004

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Primary Outcome Measures :
  1. 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.
  2. Thereafter, photographs were captured at 5, 10, and 20 minutes.
  3. ICGA results of all patients were evaluated at monthly intervals after surgery.
  4. Showing the re-vascularization during the follow-up period was the primary measure.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00383825

Baskent University Hospital Department of Ophthalmology
Ankara, Turkey, 06490
Sponsors and Collaborators
Baskent University
Study Director: Yonca A Akova, Md Bakent University Faculty of Medicine Department of Ophthalmology Identifier: NCT00383825     History of Changes
Other Study ID Numbers: B02-123456-2
First Posted: October 4, 2006    Key Record Dates
Last Update Posted: October 4, 2006
Last Verified: October 2006

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

Additional relevant MeSH terms:
Conjunctival Diseases
Eye Diseases