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Completed

NCT Number: NCT00383825

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.

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Key information

Conditions

Pterygium Conjunctival Diseases Eye Diseases

Age range

0 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baskent University Hospital Department of Ophthalmology

Ankara, 06490, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Anterior segment indocyanine green angiography

Procedure

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Baskent University

Other

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2004
First posted
Oct 4, 2006
Registry last updated
Oct 4, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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