Trial Outcomes & Findings for Optical Coherence Tomography (OCT) Data Collection Study (NCT NCT01641835)

Results Overview

The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.

Recruitment status

COMPLETED

Target enrollment

303 participants

Primary outcome timeframe

3 months

Results posted on

2016-12-19

Participant Flow

Participant milestones

Participant milestones
Measure	Normals No eye disease.
Overall Study STARTED	303
Overall Study COMPLETED	303
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Optical Coherence Tomography (OCT) Data Collection Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Normals n=303 Participants No eye disease.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	195 Participants n=5 Participants
Age, Categorical >=65 years	108 Participants n=5 Participants
Gender Female	150 Participants n=5 Participants
Gender Male	153 Participants n=5 Participants
Race/Ethnicity, Customized	303 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

The primary endpoints are the structural measurement values of (1) the ONH, (2) the peri-papillary RNFL, and (3) the macula obtained using the Spectralis OCT and the statistical descriptors such as mean, standard deviation, and distribution percentiles.

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=303 Participants Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
Primary Endpoints peri-papillary RNFL thickness, 12mm circle scan	97.2 microns Standard Deviation 9.2
Primary Endpoints peri-papillary RNFL thickness, 14mm circle scan	83.9 microns Standard Deviation 7.9
Primary Endpoints peri-papillary RNFL thickness, 16mm circle scan	73.9 microns Standard Deviation 7.0
Primary Endpoints Bruch's Membrane Opening - Minimum Rim Width, glob	336.1 microns Standard Deviation 51.6
Primary Endpoints Macula parameters have not been analyzed	NA microns Standard Deviation NA Posterior pole volume scans and macula volume scanshave been performed in order to allow future analysis of these data. This analysis was not performed yet and analysis is not planned at the moment.

PRIMARY outcome

Timeframe: 3 months

Outcome measures

Outcome measures
Measure	Healthy Volunteers n=303 Participants Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve
Bruch's Membrane Opening - Minimum Rim Area, Global	1339.3 microns^2 Standard Deviation 197.7

Adverse Events

Normals

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

Gerhard Zinser, PhD

Heidelberg Engineering GmbH

Phone: +4962216463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60