Palmitoylethanolamide intake and systemic endothelial function in ocular hypertensive patients
Not Applicable
Completed
- Conditions
- Ocular hypertensionEye Diseases
- Registration Number
- ISRCTN72647928
- Lead Sponsor
- niversity of Bologna (Italy)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1. 40 patients aged < 65 years (mean 56.8±8.1)
2. Baseline IOP >= 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
1. Cardiovascular disease
2. Diabetes, hypertension, hypercholesterolemia
3. Vasoactive medications
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. FMD values in OHT patients compared with controls at baseline <br>2. FMD values in OHT patients randomly assigned to assume Palmitoylethanolamide or placebo for 3 months <br>3. FMD values in OHT patients after 2 month washout period<br>4. FMD values in OHT patients after they switched to the other treatment for further 3 months
- Secondary Outcome Measures
Name Time Method Effect of palmitoylethanolamide vs placebo on the endothelial function of OHT patients at baseline, after treatment and wash-out