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N/A N=303

Optical Coherence Tomography (OCT) Data Collection Study

Glaucoma

Enrolled (actual)
303
Serious AEs
0.0%
Results posted
Dec 2016
Primary outcome: Primary: Primary Endpoints — 97.2; 83.9; 73.9; 336.1 microns

Study Design & Population

Study type
Observational
Phase
N/A
Interventions
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Heidelberg Engineering GmbH
Primary completion
Dec 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Primary Endpoints
97.2; 83.9; 73.9; 336.1; NA
PRIMARY
Bruch's Membrane Opening - Minimum Rim Area, Global
1339.3

Summary

Collect OCT data to evaluate the range and age trend of ocular measurements.

Eligibility Criteria

Inclusion Criteria

  • Subject is not an employee of the eye clinic.
  • Age ≥18 to 90.
  • Able and willing to undergo the test procedures, give consent, and to follow instructions.
  • Healthy eye without prior intraocular surgery (except cataract surgery and Lasik) and without clinically significant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
  • Caucasian decent (self-reported).
  • Negative history of glaucoma.
  • Intraocular pressure ≤21mmHg.
  • Best corrected visual acuity ≥0.5.
  • Refraction between +6 and -6 diopters and astigmatism ≤ 2 diopters.
  • Normal visual field with Glaucoma Hemifield Test and Mean Deviation within normal limits.
  • Clinically normal appearance of the optic disc, with normal appearing neuroretinal rim with respect to color and shape. The optic disc is examined ophthalmoscopically and by evaluation of stereo photographs.
  • When both eyes are eligible, both eyes enter the study for inter-eye asymmetry; one randomly selected eye will be used for all other measures.

Exclusion Criteria

  • Unreliable visual field. The reliability indices should be used as guide as well as the perimetrist's notes.
  • Unusable disc stereo photos.
  • Inability to undergo the tests.
  • Insufficient quality of Spectralis OCT images (this is not determined until after Spectralis OCT examination, and is an unusual circumstance). Minimum requirements are:
  • Retina completely included in image frame,
  • Quality Score ≥ 20 in the stored ART mean images, and
  • For ONH-R scan: Center position error ≤ 100 μm.
  • Note: Inability of a subject to perform one of the two scan patterns or insufficient image quality in one scan pattern does not exclude the subject or eye from the study.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01641835). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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