An interventional study of Subthreshold 577 nm yellow wavelength laser photo-coagulator in Age-Related Macular Degeneration, Geographic Atrophy and Reticular Pseudodrusen, sponsored by Ospedale San Raffaele. Completed at 1 site in Italy. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2025-03-20.
Sponsored by Ospedale San Raffaele · Not applicable, Interventional, and Treatment
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.
1,474 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 20 is below the median of 51 across 985 interventional studies indexed under Macular Degeneration.
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Exclusion Criteria:
Subthreshold 577 nm yellow wavelength laser photo-coagulator
Procedure: Subthreshold 577 nm yellow wavelength laser photo-coagulator
Subthreshold 577 nm yellow wavelength laser photo-coagulator
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.
Also known as: Pascal Synthesis 577 (Topcon), Subthreshold laser
Retinal Sensitivity
Change in retinal sensitivity on customized microperimetry (treated area).
Time frame: Baseline, 4 weeks and 12 weeks
Visual Acuity
Change in mean Visual Acuity
Time frame: Baseline, 4 weeks and 12 weeks
The Thickness of the Outer Nuclear Layer in the Treated Area
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
Time frame: Baseline, 4 weeks and 12 weeks
Number of Partecipants With Adverse and Serious Adverse Events
Adverse and Serious Adverse Events were recorded
Time frame: 4 weeks and 12 weeks
Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas
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
Intraocular pressure was recorded.
Time frame: 4 weeks and 12 weeks
| Milestone | Pseudodrusen |
|---|---|
| Started | 20 |
| Completed | 20 |
| Not completed | 0 |
Change in retinal sensitivity on customized microperimetry (treated area).
| dB | Pseudodrusen |
|---|---|
| Baseline | 12.08 ± 4.65 |
| 4 weeks | 11.08 ± 5.06 |
| 12 weeks | 11.45 ± 5.70 |
Change in mean Visual Acuity
| LogMAR | Pseudodrusen |
|---|---|
| Baseline | 0.14 ± 0.09 |
| 4 weeks | 0.135 ± 0.10 |
| 12 weeks | 0.115 ± 0.09 |
The thickness of the outer nuclear layer in the treated area was measured using structural OCT
| µm | Pseudodrusen |
|---|---|
| Baseline | 59.30 ± 13.50 |
| 4 weeks | 64.75 ± 12.31 |
| 12 weeks | 67.75 ± 15.52 |
Adverse and Serious Adverse Events were recorded
| Participants | Pseudodrusen |
|---|---|
| Number of Partecipants With Adverse and Serious Adverse Events | 0 |
Fundus examination by using slit-lamp was performed in order to assess the presence of hemorrhage, photocoagulation spots, ischemic areas
| Participants | Pseudodrusen |
|---|---|
| Number of Partecipants With Presence of Haemorrhage, Photocoagulation Spots, Ischemic Areas | 0 |
Intraocular pressure was recorded.
| mmHg | Pseudodrusen |
|---|---|
| Baseline | 15.5 ± 2.9 |
| 4 weeks | 14.9 ± 2.4 |
| 12 weeks | 14.7 ± 2.4 |
Collected over 12 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Pseudodrusen | 0/20 (0%) | 0/20 (0%) | 0/20 (0%) |
| Age, Continuous(Years) | Pseudodrusen |
|---|---|
| Mean | 78.4 ± 6.8 |
| Sex: Female, Male(Participants) | Pseudodrusen |
|---|---|
| Female | 15 |
| Male | 5 |
| Ethnicity (NIH/OMB)(Participants) | Pseudodrusen |
|---|---|
| Hispanic or Latino | 20 |
| Not Hispanic or Latino | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Pseudodrusen |
|---|---|
| Italy | 20 |
| Retinal sensitivity in the treated area(dB) | Pseudodrusen |
|---|---|
| Mean | 12.08 ± 4.65 |
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Ospedale San Raffaele