Clinical trial NCT03903588: The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Official title: The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Layer Separation
Lead sponsor: Heidelberg Engineering GmbH
Sponsor class: INDUSTRY
First posted: 2019-04-04
Enrollment: 86
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Normals, Glaucoma and Retinal Subjects as per Inclusion/Exclusion

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.


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)

Primary outcomes:
measure: Retinal Layer Thickness
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: State University of New York Optometry School
state: New York
Study officials:
References: