Back to resultsICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision
Primary Purpose
Pterygium
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Anterior segment indocyanine green angiography
Sponsored by
About this trial
This is an interventional screening trial for Pterygium focused on measuring conjunctival autografts, amniotic membrane, indocyanine green angiography, pterygium surgery
Eligibility 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
Sites / Locations
- Baskent University Hospital Department of Ophthalmology
Outcomes
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00383825
Brief Title
ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision
Official Title
Interventional Study of Vascularization Detected by ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision
Study Type
Interventional
2. Study Status
Record Verification Date
October 2006
Overall Recruitment Status
Completed
Study Start Date
January 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2004 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Baskent University
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pterygium
Keywords
conjunctival autografts, amniotic membrane, indocyanine green angiography, pterygium surgery
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
Enrollment
30 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Anterior segment indocyanine green angiography
Primary Outcome Measure Information:
Title
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.
Title
Thereafter, photographs were captured at 5, 10, and 20 minutes.
Title
ICGA results of all patients were evaluated at monthly intervals after surgery.
Title
Showing the re-vascularization during the follow-up period was the primary measure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yonca A Akova, Md
Organizational Affiliation
Bakent University Faculty of Medicine Department of Ophthalmology
Official's Role
Study Director
Facility Information:
Facility Name
Baskent University Hospital Department of Ophthalmology
City
Ankara
ZIP/Postal Code
06490
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
ICG Angiography in Amniotic Membrane Graft and Conjunctival Autograft After Pterygium Excision
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