Optical Coherence Tomography (OCT) Reference Data Collection Study (S-2015-1)

  • STATUS
    Recruiting
  • End date
    May 12, 2023
  • participants needed
    249
  • sponsor
    Heidelberg Engineering GmbH
Updated on 12 May 2022
cataract
neuropathy
retinopathy
diabetic retinopathy
corrected visual acuity
glaucoma
optical coherence tomography
intraocular pressure
Accepts healthy volunteers

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.

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.

Details
Condition Glaucoma
Treatment OCT
Clinical Study IdentifierNCT02785029
SponsorHeidelberg Engineering GmbH
Last Modified on12 May 2022

Eligibility

Yes No Not Sure

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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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