Abstract
Purpose::
To evaluate the safety and effectiveness of choroidal feeder vessel (FV) closure in the presence of indocyanine green (ICG) using a modified fundus camera for treatment of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).
Methods::
The study was a single center, prospective, randomized controlled open-label parallel group study with 2 treatment arms.Patients with FV associated with CNV were randomized into 1 of 2 treatment arms: 1 patients was treated by choroidal FV photocoagulation during ICG dye transit (FVT + ICG), the other was treated by FV photocoagulation without ICG (Control). Both treatment arms used a diagnostic/treatment system able to visualize and apply laser during ICG transit. The patients were followed and/or treated at 2, 4, 8, 12 weeks, and 6 months; with 1 additional follow up at 12 months post first treatment.
Results::
Forty patients were enrolled (20 Control/20 FVT+ICG), with 38 patients (18 Control/20 FVT+ICG) receiving at least 1 treatment with this device. The study demonstrated that the device was easy to use, and treatment session times decreased with experience with the System. The entire diagnostic, treatment and post-treatment confirmation ICG angiography took 21 to 23 minutes; this was similar for both treatment arms. On average, 4 - 5 treatment sessions were required for complete treatment in both arms over the course of the study. On average, the FVT+ICG arm used about 7 times less energy/treatment session than the Control arm (5.7 J/treatment session versus 38.9J/treatment session). Importantly, treatment was more effective and more durable in the FVT+ICG arm, as 90% of the patients were able to have their choroidal FVs closed or partially closed, with 70% of those vessels remaining closed at the last treatment assessment, compared to 77% and 44%, respectively, in the Control arm. During the course of the study, 45% fewer patients in the FVT+ICG arm went on to require alternative treatments for their wet AMD than patients in the Control arm.
Conclusions::
Data analysis suggests that feeder vessels are identifiable and treatable during the dye transit. Treatment with ICG appears to be a safe procedure. Moreover, FV photocoagulation with ICG present in the target vessel, produced a more effective and more durable treatment outcome than photocoagulation using laser only.
Keywords: age-related macular degeneration • choroid: neovascularization • laser