Reproducibility of RNFL Circle Scans With ART-Function of Heidelberg Spectralis SD-OCT Software Version 5.3

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01299233

Enrollment

100

Registered

2011-02-18

Start date

2011-02-28

Completion date

2015-12-31

Last updated

2015-01-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Patients and Healthy Controls

Brief summary

To assess the improvement in reproducibility of 100 vs. 16 averaged images by Automatic Real Time (ART) using Spectralis™ Spectral Domain-Optical Coherence Tomography (SD-OCT, Heidelberg Engineering GmbH, Heidelberg, Germany) in retinal nerve fiber layer thickness (RNFL) circle scan-measurements. * Trial with medical device

Interventions

DEVICESpectralis® SD-OCT, Heidelberg Engineering GmbH, H

Measurement of the peripapillar nerve fiber layer with different settings of ART

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

for both groups (glaucoma study group and control group): men and women of at least 50 years of age for the glaucoma study group: diagnosis of primary open angle glaucoma (POAG)

Exclusion criteria

for both groups (glaucoma study group and control group): * less then 18 years of age * any pathology of the central retina * any optic nerve disorder other then glaucoma * retinal vascular disorder for the glaucoma study group: other glaucoma diagnosis then primary open angle glaucoma for the control group: any diagnosis of glaucoma

Design outcomes

Primary

Measure	Time frame
COV	T0

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026