A pilot study to establish the efficacy and safety of supplementation with postbiotics in patients with macular degeneration.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
48
2 capsule 3 times a day, before meals
2 capsule 3 times a day, before meals
Institut de la Macula
Barcelona, Spain
RECRUITINGMicroperimetry
Median change difference in the % reduced threshold in microperimetry
Time frame: 12 months
Color vision change
Median change in red/green and yellow/blue color thresholds
Time frame: 12 months
Average Threshold microperimetry
Mean change of Average Threshold microperimetry
Time frame: 12 months
Best corrected visual acuity (BCVA)
Mean Change of Best corrected visual acuity (BCVA)
Time frame: 12 months
Low luminance visual acuity (LLVA)
Mean Change of Low luminance visual acuity (LLVA)
Time frame: 12 months
Rod and cone sensitivity
Mean change of Rod and cone sensitivity test
Time frame: 12 months
Advanced Vision and Optometric Test (AVOT)
Mean change AVOT vision test
Time frame: 12 months
incomplete retinal pigment epithelial and outer retinal atrophy (iRORA) conversion loci
Number of scans within the optical coherence tomography OCT cube as as per protocol (Spectralis OCT cube protocol: 20º x 20ª, 97b-scan, high-resolution, 62 microns between scans centered at the fovea) with features of iRORA2 conversion loci (change from baseline to 12 months of iRORA loci).
Time frame: 12 months
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complete retinal pigment epithelial and outer retinal atrophy (cRORA) conversion loci
Number of scans within the OCT cube as as per protocol with of features of cRORA (change from baseline to 12 months of cRORA loci).
Time frame: 12 months
Area of cumulative cRORA conversion
Area of cumulative cRORA conversion as measured in mm2 by en face OCT projection scans of the OCT cube as as per protocol
Time frame: 12 months
Hyperreflective dots(HRD)+ (retinal pigment epithelium)RPE defects areas conversion
Number of scans within the OCT cube as as per protocol with HRD+RPE defects areas conversion (change from baseline to 12 months of HRD+RPE defects)
Time frame: 12 months
Change in outer nuclear layer (ONL) volume
Change in outer nuclear layer (ONL) volume measured by the spectralis software after manually correction of the layer segmentation
Time frame: 12 months
Change of drusen > 100 microns height
Change of number of drusen of \> 100 microns height measured by OCT within the OCT cube as as per protocol
Time frame: 12 months
Change of subretinal drusenoid deposits (SDD) through ellipsoid zone (ELZ)
Change of number of subretinal drusenoid deposits (SDD) through ellipsoid zone within the OCT cube as as per protocol
Time frame: 12 months
Change of SDD ribbon
Change of number SDD ribbon within the OCT cube as as per protocol
Time frame: 12 months
Conversion to choroidal neovascularization (CNV)
Any conversion to any type of macular neovascularization (MNV) within the OCT cube as as per protocol 1 as per OCT features of leakage, and/or intrarretinal, subretinal or subRPE fluid, and/or presence of Subretinal hyperreflective material(SHRM)
Time frame: 12 months