Trial Outcomes & Findings for Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) (NCT NCT02609204)

Last Updated: 2018-12-04

Results Overview

Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.

Recruitment status

COMPLETED

Study phase

Target enrollment

51 participants

Primary outcome timeframe

2 hours

Results posted on

2018-12-04

Participant Flow

Participant milestones

Participant milestones
Measure	Healthy Controls 51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA (Neuro Optic Vision Assessment). Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
Overall Study STARTED	51
Overall Study COMPLETED	51
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Normative Database for Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Healthy Controls n=51 Participants 51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA. Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
Age, Continuous	53.3 years n=5 Participants
Sex: Female, Male Female	30 Participants n=5 Participants
Sex: Female, Male Male	21 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	20 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	18 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	51 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 hours

Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) amplitude in micro volts.

Outcome measures

Outcome measures
Measure	Healthy Controls n=51 Participants 51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA. Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
Flash Electroretinogram (FERG) Module Using Diopsys NOVA (Neuro Optic Vision Assessment) Amplitude	-1.68 micro volts Standard Deviation 0.78

PRIMARY outcome

Timeframe: 2 hours

Clinical data from participants with a normal eye examination to establish expected normal values of Flash Electroretinogram (FERG) photopic negative response (PhNR) latency in milliseconds.

Outcome measures

Outcome measures
Measure	Healthy Controls n=51 Participants 51 Participants with normal eye exams and no history of eye diseases will best tested with Diopsys NOVA. Diopsys NOVA: Healthy Controls will have both eyes tested by the Diopsys NOVA machine using Pattern Electroretinogram (PERG) and Flash Electroretinogram (FERG) modules.
Flash Electroretinogram (FERG) Module Using Diopsys NOVA Latency	107.39 milliseconds Standard Deviation 10.22

Adverse Events

Healthy Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. L. Jay Katz

Wills Eye Hospital, Glaucoma Research Center

Phone: 215-928-3123

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place