Pascal Synthesis 577 sub-threshold laser (Topcon Corporation, Tokyo, Japan)
DeviceThe subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.
NCT Number: NCT04847635
Prospective, randomized, controlled, longitudinal, interventional multicentric study involving patients with reticular pseudodrusen secondary to AMD.
The objective of this study is to establish the effectiveness of subthreshold laser treatment in increase/prevent the decrease of the retinal sensibility in patients with reticular pseudodrusen, and to reduce the progression of RPD to atrophy.
Approximately 50 naïve patients with reticular pseudodrusen who underwent subthreshold laser treatment in perifoveal area. These patients should be randomized in the 2 study arms of the study. Patients will be evaluated at Screening/Baseline and then revaluated and retreated at month 3, 6 and 9. At month 12, all patients will be evaluated with a full ocular examination, visual acuity measurement (VA), optical coherence tomography (OCT) with autofluorescence, OCT-angiography and microperimetry.
The rationale of the study is to prevent the evolution of reticular pseudodrusen to atrophic degeneration.
Interested in participating?
Request Info55 year and older
All sexes
Interventional
Not applicable
Massimo Nicolò, Genova, Italy
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The subthreshold laser treatment will be performed using subthreshold laser Pascal Synthesis 577 on a customized macular area.
The laser treatment will be performed without any power (only the light beam) using subthreshold laser Pascal Synthesis 577 on a customized macular area.
Time frame: 12 months
Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 12 (unit of measure: dB)
Time frame: 12 months
Anatomical changes will be evaluated with retinal thickness (unit of measure: microns)
Time frame: 12 months
Rate of progression to advance AMD (GA and/or neovascular AMD)
Time frame: 6 months
Functional changes in the retinal sensitivity on customized microperimetry from day 0 to month 6 (unit of measure: dB)
Time frame: 12 months
Anatomical changes will be evaluated analyzing the development of geographic atrophy using FAF
Time frame: 12 months
The % of AMD-associated single-nucleotide polymorphism (SNP) will be evaluated analyzing the % of patients with an AMD-associated SNP in patients showing no progression vs progression to advance AMD (main outcome 3).
Time frame: 12 months
Anatomical changes will be evaluated analyzing the perfusion density by means of OCT-A
Contact information is provided by the study sponsor or research team.
Ospedale San Raffaele
Other
Acronym: PASCAL-RPD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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