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Chiara Lumini, Luigia Scudeller, Federica Bettio, Erica Picasso, Gian Maria Pasinetti, Gemma Caterina Rossi; Effect of Palmitoylethanolamide (PEA) on inner retinal function in stable glaucoma patients. A prospective, randomized, single blind, crossover, clinical trial by pattern electroretinogram.. Invest. Ophthalmol. Vis. Sci. 2018;59(9):1254.
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© ARVO (1962-2015); The Authors (2016-present)
Glaucoma is a neurodegeneration involving retinal ganglion cells (RGC): neuroprotection is considered an additional therapeutic strategy. PEA acts on dopamine release in cones and bipolar cells.We evaluated the benefit of PEA 600 mg on RGCs function and assessed effects on IOP, visual field VF, quality of life (QoL).
Monocentric, randomized, single blind, phase II, crossover study on OAG, age >18 ys; controlled and stable IOP; stable disease. At baseline, M4 and M8 patients underwent ophthalmic examination, PERG, VF, QoL evaluation (NEIVFQ25).Patients were randomized to group A (PEA) or to group B (current topical therapy) for 4 months, then were crossed-over. Statistical analysis.Sample size was set at 20 patients for group to achieve 87% power to infer that mean difference is not 1.0, the actual mean difference is 2.1, the standard deviation of the period differences for each subject within each sequence is 0.7, the significance level is 0.05, with a two-sided t-test.Descriptive statistics, parametric/non-parametric tests, Fisher exact test were used. Linear regression models for repeated measures were used to include both eyes per patients and trends over time.
40 patients completed the study: 21 (52.5%) male; 22 (66,5%) POAG; median age 66.7 [61.3-73.2], IOP 14 [12-16] mmHg; MD VF defect mild; PERG ampP50 1.55 [.85-2.2] for RE and 1.2 [.7-1.9] for LE, latP50 55.5 [53- 61] and 57 [53.5-60.5], ampN95 2.3 [1.5-3.5] for RE and 3 [1.9-3.5] for LE, latN95 102 [98-106.5] and 100 [96.5-107.5]; QoL total score 65 [60-71.3]. At baseline all data were similar. There were no carry over effects for any of the outcomes considered: all data were used for all patients. After the treatment with PEA 600 mg a significant increase of PERG p50 amplitude was found (p=.048), no effects were observed regarding latency. About IOP a reduction of 0.5 mmHg was observed (p=.08). VF indices did not significantly change over the considered time, QoL score significantly improved with PEA assumption (p<.0001).
Treatment with PEA induces an enhancement in the inner retinal function in stable glaucomas, it may also reduce IOP and improve quality of life. Considering the phase II stage and the small number of patients, larger, phase III studies are warranted.
This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.
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