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The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study

H

Heidelberg Engineering

Status

Completed

Conditions

Retinal Layer Separation

Treatments

Device: Optical Coherence Tomography

Study type

Observational

Funder types

Industry

Identifiers

NCT03903588
S-2018-2

Details and patient eligibility

About

This is a prospective clinical study that will be conducted at one clinical site located in the United States to assess two grids.

Enrollment

86 patients

Sex

All

Ages

22+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion All Eye Populations

  • Age 22 years or older
  • Able and willing to undergo the test procedures, sign informed consent, and follow instructions
  • Able to fixate
  • Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
  • Axial length ≤ 26.0 mm

Exclusion All Eye Populations

  • Subjects unable to read or write
  • Ocular media is not sufficiently clear to obtain acceptable quality images
  • Physical inability to be properly positioned at the study devices or eye exam equipment

Inclusion Normal Population

  • Eyes without prior intraocular surgery bilaterally (except cataract surgery and LASIK)
  • Intraocular pressure ≤ 21mmHg
  • Best corrected visual acuity ≥ 20/40
  • Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape, and clinically normal appearing posterior pole
  • Both eyes must be determined to be normal, as determined by an investigator

Exclusion Normal Population

  • Subjects with vitreal, retinal or choroidal conditions or disease of the optic nerve. Subjects may have diabetes but cannot have diabetic retinopathy.
  • History of glaucoma (not including family history)
  • Unreliable visual field as determined by the manufacturer's recommendations of:

Fixation losses > 20%, False Positives > 33%, False Negatives > 15%

-Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits"

Inclusion Glaucoma Population

  • Subjects who have a glaucoma diagnosis without prior non-glaucoma related intra-ocular surgery (except cataract surgery and LASIK)
  • Glaucomatous optic nerve damage as evidenced by any of the following optic disc or retinal nerve fiber layer structural abnormalities:

Diffuse thinning, focal narrowing, or notching of the optic disc rim, especially at the inferior or superior poles with or without disc hemorrhage; Localized abnormalities of the peripapillary retinal nerve fiber layer, especially at the inferior or superior poles; or Optic disc neural rim asymmetry of the two eyes consistent with loss of neural tissue

  • Visual field defects consistent with glaucomatous optic nerve damage based on at least one of the following two findings:
  • On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test "outside normal limits."
  • Best corrected visual acuity ≥ 20/40

Exclusion Glaucoma Population

  • Subjects with presence of any ocular pathology other than Glaucoma in the study eye (cataracts are acceptable)
  • Unreliable visual field as determined by the manufacturer's recommendations of:

Fixation losses > 20%, False Positives > 33%, False Negatives > 15%

Inclusion Retina Population

  • Subjects who have a retinal condition diagnosis without prior non-retinal related intra-ocular surgery (except cataract surgery and LASIK).
  • Intraocular pressure ≤21mmHg
  • Best corrected visual acuity ≥20/400

Exclusion Retina Population

-Subjects with presence of any ocular pathology other than retinal conditions in the study eye (cataracts are acceptable)

Trial design

86 participants in 3 patient groups

Normal
Description:
Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.
Treatment:
Device: Optical Coherence Tomography
Glaucoma
Description:
Eyes that have been diagnoses with Glaucoma
Treatment:
Device: Optical Coherence Tomography
Retinal Disease
Description:
Eyes that have been diagnoses with a Retinal Disease
Treatment:
Device: Optical Coherence Tomography

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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