Subthreshold Laser Treatment for Reticular Pseudodrusen and Geographic Atrophy Secondary to AMD
NCT02800356 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20
Last updated 2025-03-20
Summary
To evaluate the effectiveness of subthreshold laser treatment on retinal sensitivity in patients with reticular pseudodrusen and incipient Geographic Atrophy (GA) secondary to Age-Related Macular Degeneration (AMD). Secondary objective is to investigate changes in best-corrected visual acuity, atrophy progression and safety.
Conditions
- Age-Related Macular Degeneration
- Geographic Atrophy
- Reticular Pseudodrusen
Interventions
- PROCEDURE
-
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Subthreshold photocoagulation is a method in which the burn spots (treated areas) cannot be seen with biomicroscopy, on color fundus photograph, on Optical Coherence Tomography or Fluorescein Angiography when the subthreshold level is adequately set. Subthreshold photocoagulation can be considered to be truly minimally invasive or non-damaging photocoagulation. A term sometimes used is photo-thermal stimulation since the Retinal Pigment Epithelium (RPE) layer is heated and stimulated, but not destroyed. The threshold level output power is set to obtain barely visible burn at approximately 200 mW to 250 mW using the titration mode, and irradiation is conducted after switching over to Endpoint Management.
Sponsors & Collaborators
-
Ospedale San Raffaele
lead OTHER
Principal Investigators
-
Giuseppe Querques, MD, PhD · Ospedale San Raffaele
-
Riccardo Sacconi, MD · Ospedale San Raffaele
-
Francesco Gelormini, MDs · Ospedale San Raffaele
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 50 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-06-30
- Primary Completion
- 2019-09-01
- Completion
- 2019-09-01
Countries
- Italy
Study Locations
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