The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study

NCT03903588 | Completed FDA Device

• 1 other identifier: S-2018-2
• Study Type: observational
• Target: 86
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Retinal Layer Thickness

  Measurement of the thickness of Retinal layers thickness to assess 2 grids

  5 months

Study Arms (3)

Normal

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

Device: Optical Coherence Tomography

Glaucoma

Eyes that have been diagnoses with Glaucoma

Device: Optical Coherence Tomography

Retinal Disease

Eyes that have been diagnoses with a Retinal Disease

Device: Optical Coherence Tomography

Interventions

Optical Coherence Tomography DEVICE

Imaging of the Retina

Also known as: OCT

Glaucoma; Normal; Retinal Disease

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Normals, Glaucoma and Retinal Subjects as per Inclusion/Exclusion

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)

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Heidelberg Engineering GmbH: lead

Study Sites (1)

State University of New York Optometry School

New York, New York, 10036, United States

Location

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2019
• First Posted: April 4, 2019
• Study Start: March 22, 2019
• Primary Completion: September 12, 2019
• Study Completion: September 12, 2019
• Last Updated: October 22, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)