Purchase this article with an account.
Silvia N Simao; Multifocal electroretinography to evaluate retinal function in the setting of a multicenter clinical trial. Invest. Ophthalmol. Vis. Sci. 2016;57(12):3591.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
Development of a multifocal electroretinography (mfERG) normative database to evaluate the retinal function in the context of a multicenter clinical trial.
mfERG (103-hexagons) was performed in 77 volunteers with age between 45-75years and BCVA≥20/25, using the RETI-port/scan21 (Roland Consult) in 11 European clinical sites participating in the EUROCONDOR study (NCT01726075), after technician’s certification. Every equipment was set up with fixed acquisition parameters. Standardized mfERG acquisition protocol was established and the equipment and technicians were trained and certified by the Coimbra Ophthalmology Reading Center (CORC). A mfERG normative database was established and the amplitude (nV/deg2) and implicit time (ms) of the P1 peak were calculated for each hexagon and the following measurements were performed: six concentric rings, upper and lower retinal hemifields, nasal and temporal retinal hemifields, and in the 35 retinal zones. Influence of age and gender were analyzed. Each of the 103 hexagons was compared in Implicit Time and Amplitude between Clinical Sites by three-way factorial ANOVA, controlling for age and gender, applying Bonferroni correction for multiple comparisons (α=0.0002).
The normative database was based on 111 healthy eyes from 77 volunteers, 75% females. The mean of the P1 implicit time for all 111 healthy eyes was 33.94±1.70 ms. The range of standard deviation (SD) by hexagon was 2.14 to 3.79 ms (median 2.67 ms; 95th percentile, 3.52 ms). The overall mean P1 amplitude was 30.58±5.20 nV/deg2, while its SD ranged from 4.80 to 26.42 nV/deg2 (median 7.13 nV/deg2; 95th percentile, 17.10 nV/deg2). The responses that were averaged in the six rings showed a P1 implicit time longer at the fovea, shorter at the parafovea and again longer at the perifovea. The P1 amplitude values decreased with eccentricity from the fovea. Implicit time is longer in males (p=0.006) and increases with age (p=0.003). Amplitude and Implicit Time did not vary significantly between Clinical Sites (p>0.0002).
The study showed that mfERG is a viable retinal function examination in the context of a multicenter clinical trial with standardized acquisition procedures and a centralized reading centre.
This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.
This PDF is available to Subscribers Only