Ocular hypertension Eye Diseases Ocular hypertension
Conditions
Interventions
Treatment arms: 20 OHT patients randomly assigned to assume a 300 mg oral tablet of palmitoylethanolamide (PEA) two time a day for three months and after two months of wash out switched to treatment w
FMD was calculated as the percentage change in brachial artery diameter in response to reactive hyperemia:
FMD = [(VDHyperemia ? VDBaseline)/ VDBaseline] x 100%
VD= Vessel Diameter
Sponsors
University of Bologna (Italy)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. 40 patients aged = 22 mm/Hg, on at least two measurements (mean 23.11±0.93) 3. Open anterior chamber angle at gonioscopy, cup/disc ratio < 0.4 4. Normal visual field (VF) (MD <3 dB and PSD < 2.5 dB) and corneal central thickness within normal values 5. 40 healthy control subjects aged matched (mean 56.2±10.4)
Exclusion criteria
Exclusion criteria: 1. Cardiovascular disease 2. Diabetes, hypertension, hypercholesterolemia 3. Vasoactive medications
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. FMD values in OHT patients compared with controls at baseline 2. FMD values in OHT patients randomly assigned to assume Palmitoylethanolamide or placebo for 3 months 3. FMD values in OHT patients after 2 month washout period 4. FMD values in OHT patients after they switched to the other treatment for further 3 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Effect of palmitoylethanolamide vs placebo on the endothelial function of OHT patients at baseline, after treatment and wash-out | — |
Countries
Italy
Outcome results
None listed