Effects of Palmitoylethanolamide on Inner Retinal Function in Glaucoma Patients by Pattern Electroretinogram
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|ClinicalTrials.gov Identifier: NCT04088084|
Recruitment Status : Completed
First Posted : September 12, 2019
Last Update Posted : September 12, 2019
The general purpose of the study is to evaluate the potential beneficial effects of PEA 600 mg supplementation on RGCs function in subjects with glaucoma by pattern electroretinogram after three months of therapy.
Secondary objectives are to assess effects on intraocular pressure (IOP) values, if any; to record visual acuity, visual field, central corneal thickness (CCT), and Optical coherence tomography (OCT) (ganglion cell complex - GCC) changes, if any and to follow quality of life (QL) perception (general vision -GV and general health - GH of national eye instutute visual functioning questionnaire 25 items - NEI VFQ25)
|Condition or disease||Intervention/treatment||Phase|
|Glaucoma||Dietary Supplement: palmitoylethanolamide (PEA) 600 mg||Phase 2|
Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
The investigators have proposed a cross-over trial to avoid or to detect the bias due to intra-individual variability and because, from preliminary observation, it has been noted that the effects of PEA on pattern-electroretinogram (PERG) are completely reversible after withdrawal, within one month.
The investigators didn't considered a placebo treated group because the patient cannot interfere with the pattern-electroretinogram PERG measurement that is objective and totally patient-independent.
Study duration 12 months Enrolment period 6 months Minimum Follow-up 6 months Start: January, 2015; end January, 2016 Total sample size: 40 patients
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Crossover Assignment|
|Intervention Model Description:||Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Masking Description:||examiners were blinded to the assumption or not of PEA in addition to topical therapy|
|Official Title:||Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.|
|Actual Study Start Date :||March 9, 2015|
|Actual Primary Completion Date :||December 31, 2017|
|Actual Study Completion Date :||December 31, 2017|
Experimental: standard of care+palmitoylethanolamide
PEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med)
Dietary Supplement: palmitoylethanolamide (PEA) 600 mg
PEA 600 mg was added to topical therapy
No Intervention: standard of care
patients were only on topical IOP lowering therapy (SOC)
- To assess effects of PEA 600 mg a tablet a day on pattern electroretinogram PERG examination at three months of therapy. [ Time Frame: 3 months ]changes in amplitude (microVolt) and changes in latency (millisecond) of p50 and n95 waves
- To assess effects of PEA 600 mg on intraocular pressure (IOP) values [ Time Frame: 3 months ]IOP measure in mmHg
- To record visual field changes [ Time Frame: 3 months ]changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters
- To follow quality of life - QL - perception using the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) [ Time Frame: 3 months ]changes in the total mean score, in the General vision -GV- and in the general health -GH- subscales scores (scores are presented as a number, higher numbers reflect higher QL)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088084
|Principal Investigator:||gemma caterina maria rossi, md||clinica oculistica|