Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03903588
Recruitment Status : Recruiting
First Posted : April 4, 2019
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

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.

Condition or disease Intervention/treatment
Retinal Layer Separation Device: Optical Coherence Tomography

Layout table for study information
Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Heidelberg Engineering SPECTRALIS Macular Precision and Agreement Study
Actual Study Start Date : March 22, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Group/Cohort Intervention/treatment
Normal
Eyes judged as age-appropriate normal as determined by an Investigator and that meet applicable inclusion/exclusion criteria.
Device: Optical Coherence Tomography
Imaging of the Retina
Other Name: OCT

Glaucoma
Eyes that have been diagnoses with Glaucoma
Device: Optical Coherence Tomography
Imaging of the Retina
Other Name: OCT

Retinal Disease
Eyes that have been diagnoses with a Retinal Disease
Device: Optical Coherence Tomography
Imaging of the Retina
Other Name: OCT




Primary Outcome Measures :
  1. Retinal Layer Thickness [ Time Frame: 5 months ]
    Measurement of the thickness of Retinal layers thickness to assess 2 grids



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Normals, Glaucoma and Retinal Subjects as per Inclusion/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)


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03903588


Contacts
Layout table for location contacts
Contact: Monica Joao (212) 938-4056 mjoao@sunyopt.edu

Locations
Layout table for location information
United States, New York
State University of New York Optometry School Recruiting
New York, New York, United States, 10036
Contact: Monica Joao    212-938-4056    mjoao@sunyopt.edu   
Sponsors and Collaborators
Heidelberg Engineering GmbH

Layout table for additonal information
Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT03903588     History of Changes
Other Study ID Numbers: S-2018-2
First Posted: April 4, 2019    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No