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Completed

NCT Number: NCT04088084

Effects of Palmitoylethanolamide on Inner Retinal Function in Glaucoma Patients by Pattern Electroretinogram

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)

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • -age 18 years or older
  • diagnosis of primary open angle glaucoma (POAG)
  • controlled IOP (<18 mmHg, morning value) with any topical lowering medication (beta-blockers, carbonic anhidrase inhibitors, alpha2agonists, prostaglandin analogues as monotherapy or as associative therapy; betablocker/carbonic anhydrase inhibitor, betablocker/alpha2agonist, prostaglandine/betablocker and alpha2agonist/carbonic anhidrase inhibitor fixed combinations as monotherapy or in association);
  • stable IOP<18 mmHg in the last 2 years
  • stable disease in the last 2 years (no more than -1 deciBell-dB/year at MD of visual field)
  • at least two reliable visual fields per year in the last 2 years
  • no filtering surgery or other ocular surgery in the preceding 6 months
  • written consent to participate to study procedures and data utilization in an anonymous form

Exclusion criteria

  • ocular hypertension with normal optic nerve and visual field
  • contraindication to PEA
  • glaucomatous scotomas within 10 degree from fixation
  • any condition limiting the patient's ability to participate in the study;
  • other causes of visual field changes, such as cataract, myopic chorioretinopathy, macular diseases, retinal vascular occlusion

Treatment and study plan

palmitoylethanolamide (PEA) 600 mg

Dietary Supplement

PEA 600 mg was added to topical therapy

Primary outcomes

  1. 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

Secondary outcomes

  1. To assess effects of PEA 600 mg on intraocular pressure (IOP) values

    Time frame: 3 months

    IOP measure in mmHg

  2. 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

  3. 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)

Sponsors and collaborators

Lead sponsor

Fondazione IRCCS Policlinico San Matteo di Pavia

Other

Registry information

Official study title

Effect of Palmitoylethanolamide on Inner Retinal Function in Stable Glaucoma Patients. A Prospective, Randomized, Single Blind, Crossover Clinical Trial by Pattern Electroretinogram.

Important dates

Study start
2015
Primary completion
2017
Study completion
2017
First posted
Sep 12, 2019
Registry last updated
Sep 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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