Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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)
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard of care+palmitoylethanolamide | Experimental | PEA was supplemented for 3 months to the standard of care (SOC, topical IOP lowering med) |
|
| standard of care | No Intervention | patients were only on topical IOP lowering therapy (SOC) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| palmitoylethanolamide (PEA) 600 mg | Dietary Supplement | PEA 600 mg was added to topical therapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| To assess effects of PEA 600 mg a tablet a day on pattern electroretinogram PERG examination at three months of therapy. | changes in amplitude (microVolt) and changes in latency (millisecond) of p50 and n95 waves | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| To assess effects of PEA 600 mg on intraocular pressure (IOP) values | IOP measure in mmHg | 3 months |
| To record visual field changes | changes in MD (deciBell-dB) and pattern standard deviation-PSD (deciBell-dB) of visual field parameters |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| gemma caterina maria rossi, md | clinica oculistica | Principal Investigator |
Not provided
data will be published on peer review journal
upon publication
actually not available
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 20, 2014 | Sep 10, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C005958 | palmidrol |
Not provided
Not provided
Not provided
Monocentric, randomized, prospective, single blind, two treatment and two period crossover study.
Not provided
Not provided
examiners were blinded to the assumption or not of PEA in addition to topical therapy
| 3 months |
| To follow quality of life - QL - perception using the 25 item National Eye Institute - Visual Functioning Questionnaire (NEI VFQ25) | 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) | 3 months |