Clinical trial NCT02785029: Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
Official title: Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Glaucoma
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2016-05-27
Enrollment: 234
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy eyes without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve from subjects of Black or African-American decent (self-reported)

Brief summary: This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes.

Detailed description: This prospective, single-arm clinical multicenter study intends to measure normal structural parameters of the optic nerve head, the peripapillary retinal nerve fiber layer, and the macula using the Heidelberg Spectralis OCT device. This study is conducted in African-American descent volunteers. The main goal of the study is to provide the range of these structural parameters in normal eyes. The study will include at least 240 normal volunteers; up to 10 study sites will recruit subjects. Overall an approximately equal age distribution from 18 to 90 years and an approximately equal number of females and males will be enrolled (approximately 40-60% females in each age group). All subjects will undergo Spectralis OCT imaging, biometric and ophthalmoscopic examination, disc photography and visual field testing in one single visit, if possible. Repeated perimetry or Spectralis scans may be performed at a second visit within 30 days of the initial visit. All examinations performed on the subjects are non-significant risk procedures.

Eligibility criteria: Inclusion Criteria:

* Able and willing to undergo the test procedures, give consent, and to follow instructions.
* Signed informed consent
* Age ≥18 to 90.
* Healthy eye without prior intraocular surgery (except cataract surgery and Laser in Situ Keratomileusis) and without clinically significant vitreal, retinal or choroidal diseases, clinically significant diabetic retinopathy (subject may have diabetes), or disease of the optic nerve. Small drusen are acceptable in older subjects.
* Black or African-American decent (self-reported)
* Negative history of glaucoma (not including family history)
* Intraocular pressure ≤21mmHg.
* Best corrected visual acuity ≥20/40.
* Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
* Axial length ≤ 26.0 mm (by optical biometry)
* Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits or not abnormal visual field by judgment of the ophthalmologist / optometrist
* Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
* If both eyes are eligible, both eyes enter the study.

Exclusion Criteria:

* Vulnerable subjects (as defined in ISO 14155 GCP) with the exception of employees of the site, and, if applicable, students of the respective university. Staff that is listed on the delegation form are excluded from participation.
* Subjects unable to read or write
* Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
* Unusable disc stereo photos.
* Inability to undergo the tests.
* Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance).

Minimum requirements are:

* Retina completely included in image frame,
* Quality Score ≥ 20 in the stored ART mean images, and
* For ONH-R scan: Center position error ≤ 100 μm.

Primary outcomes:
measure: Bruch-Membrane-Opening - Minimum Rim Width (µm)
timeFrame: Baseline
measure: Bruch-Membrane-Opening - Minimum Rim Area (µm^2)
timeFrame: Baseline
measure: Peripapillary Retinal Nerve Fibre Layer Thickness (µm)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University California San Diego
state: California
city: Santa Monica
country: United States
facility: Assil Eye Institute
state: California
city: Mount Dora
country: United States
facility: Mid Florida Eye Center Clinic
state: Florida
city: Chicago
country: United States
facility: Illinois Eye Institute, Illinois College of Optometry
state: Illinois
city: Jamaica
country: United States
facility: St Albans Community Living, Center, Queens Campus
state: New York
city: New York
country: United States
facility: SUNY College of Optometry
state: New York
city: Valley Stream
country: United States
facility: Ophthalmic Consultants of Long Island-Valley Stream
state: New York
city: Philadelphia
country: United States
facility: Wills Eye Hospital
state: Pennsylvania
Study officials:
affiliation: Department of Ophthalmology and Visual Sciences Dalhousie University
name: Balwantray Chauhan, OD
role: PRINCIPAL_INVESTIGATOR
References: