Ospedale San Raffaele
Milan, MI, 20132, Italy
NCT Number: NCT02800356
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.
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Notify Me50 year and older
All sexes
Interventional
Not applicable
Milan, MI, 20132, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: Pascal Synthesis 577 (Topcon), Subthreshold laser
Time frame: Baseline, 4 weeks and 12 weeks
Change in retinal sensitivity on customized microperimetry (treated area).
Time frame: Baseline, 4 weeks and 12 weeks
Change in mean Visual Acuity
Time frame: Baseline, 4 weeks and 12 weeks
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Time frame: 4 weeks and 12 weeks
Adverse and Serious Adverse Events were recorded
Time frame: 4 weeks and 12 weeks
Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas
Time frame: 4 weeks and 12 weeks
Intraocular pressure was recorded.
Ospedale San Raffaele
Other
Subthreshold Laser Treatment for Reticular Pseudodrusen and Incipient Geographic Atrophy Secondary to Age - Related Macular Degeneration: a Pilot Study
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