The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Launched by HEIDELBERG ENGINEERING GMBH · Apr 3, 2019
Trial Information
Current as of July 22, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility 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)
About Heidelberg Engineering Gmbh
Heidelberg Engineering GmbH is a leading global developer of innovative diagnostic and therapeutic solutions for eye care. With a strong focus on advancing ophthalmic technology, the company specializes in high-resolution imaging systems, data management software, and integrated clinical workflows that enhance patient care and streamline clinical processes. Committed to research and development, Heidelberg Engineering collaborates with healthcare professionals and institutions worldwide to improve understanding and treatment of ocular diseases. Through its dedication to quality and innovation, the company aims to empower clinicians with the tools necessary for accurate diagnosis and effective patient management.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
New York, New York, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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