Clinical trial NCT02247284: Reproducibility of RNFL and ONH Measurements in OAG With Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition
Official title: Study to Investigate Reproducibility of the New Heidelberg Spectralis SD-OCT Glaucoma Module Premium Edition (Software Version 6.0) in Comparison to Reproducibility of RNFL Scans.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2014-09-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with a new software (glaucoma premium module) with the well established peripapillary RNFL thickness measurements in patients with primary open angle glaucoma.

Detailed description: The purpose of this study is to assess and compare the repeatability of SD-OCT (Spectralis™ OCT, Version 6.0, Heidelberg Engineering, Germany) RNFL thickness measurements with the new software (method B) and with the previous method of measurement (method A) in patients with glaucoma.

It is a prospective, not blinded, not randomised, monocentric study. Inclusion of 50 patients with a diagnosis of primary open angle glaucoma (POAG), that will be recruited from the ophthalmology outpatient department of the UniversityHospital Zurich, Switzerland. All patients will undergo a full ophthalmic examination including measurement of refraction, best corrected visual acuity, examination of anterior and posterior compartment and measurement of the intraocular pressure. On the same day they will have 3 OCT examinations with a new method of measurement (method B).On the same day the first 10 patients will undergo also 3 OCT examinations with the previous method (method A) and they will get an other 3 OCT examinations with method B by a second observer. For this 10 patients the next consultation (3 months +/- 1 month) the 3 OCT examinations with method B will be repeated by the first observer.

Primary objectives are coefficient of variations (COV) of method A and B; Intra-class-correlations (ICC) of method A and B.

Eligibility criteria: Inclusion Criteria:

* diagnosis of POAG glaucoma
* male and female patients aged 18 years or older, no upper limit
* written informed consent
* visual acuity of more or equal to 0.5 Snellen
* refractive error between + /- 6.00 D spheric and under or equal than 2.00 D cylindrical

Exclusion Criteria:

* history of surgery other than uncomplicated cataract surgery
* disease affecting cornea, anterior compartment, lens, vitreous body
* history of severe ocular disease, particularly diseases affecting the optic nerve, other than glaucoma
* history of ocular trauma

Primary outcomes:
measure: Retinal nerve fiber layer thickness (RNFL)
timeFrame: baseline and 3 months +/- 1 month
measure: Bruch's membrane opening-based minimum rim width (BMO-MRW)
timeFrame: baseline and 3 months +/- 1 month
Secondary outcomes:
measure: Coefficient of variations (COV) of RNFL and BMO-MRW
timeFrame: baseline and 3 months +/- 1 month
measure: Intra-class-correlations (ICC) of RNFL and BMO-MRW
timeFrame: baseline and 3 months +/- 1 month
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: UniversityHospital Zurich
state: ZH
Study officials:
affiliation: UniversityHospital Zurich, Zurich, Switzerland
name: Jens Funk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: