The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study

NCT ID: NCT03903588

Last Updated: 2020-10-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 86 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2019-09-12

Brief Summary

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

Conditions

Retinal Layer Separation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Normal

Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.

Optical Coherence Tomography

Intervention Type: DEVICE

Imaging of the Retina

Glaucoma

Eyes that have been diagnoses with Glaucoma

Optical Coherence Tomography

Intervention Type: DEVICE

Imaging of the Retina

Retinal Disease

Eyes that have been diagnoses with a Retinal Disease

Optical Coherence Tomography

Intervention Type: DEVICE

Imaging of the Retina

Interventions

Optical Coherence Tomography

Imaging of the Retina

Intervention Type: DEVICE

Other Intervention Names

OCT

Eligibility Criteria

Inclusion Criteria

• 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)

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Heidelberg Engineering GmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

State University of New York Optometry School

New York, New York, United States

Countries

United States

Other Identifiers

S-2018-2

Identifier Type: -

Identifier Source: org_study_id