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

Not Applicable

Completed

• Conditions: Pterygium

• Registration Number: NCT00383825
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2003-01
• Study Completion: 2004-12
• Status Verified: 2006-10
• Study First Submitted: 2006-10-02
• Study First Submitted QC: 2006-10-02
• Last Update Submitted: 2006-10-02
• Study First Posted: 2006-10-04
• Last Update Posted: 2006-10-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Baskent University Hospital Department of Ophthalmology; 🇹🇷 Ankara, Turkey