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N/A N=109 Randomized Single-blind Diagnostic

Clinical Study of the Optic Disc Parameters

Normal Healthy Subjects With No Known Ocular Diseases · Glaucomatous Eyes · Eyes With Retinal Diseases

Bottom Line

View on ClinicalTrials.gov: NCT02277119 ↗
Enrolled (actual)
109
Serious AEs
0.0%
Results posted
Nov 2016
Primary outcome: Primary: Optic Disc Measurements (Optic Disc Size) — 0.197; 0.097; 0.201 Mircrons squared

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Maestro (Device); iVue (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Topcon Medical Systems, Inc.
Primary completion
Jan 2015

Outcome Measures

OutcomeResultp-value
PRIMARY
Optic Disc Measurements (Optic Disc Size)		 0.197; 0.097; 0.201 —
PRIMARY
Retinal Nerve Fiber Layer (RNFL) Thickness Measurements		 4.682; 2.526; 4.103 —
PRIMARY
Full Retinal Thickness Measurement		 22.845; 21.299 —
PRIMARY
Optic Disc Measurement (Cup Size)		 0; -0.003; 0.016 —

Summary

Assess the repeatability and agreement of the Optic Disc Parameters, Retinal Nerve Fiber Layer (RNFL) Thickness, and Full Retinal Thickness between the Maestro and iVue OCT devices

Eligibility Criteria

Inclusion Criteria for Normal Group

  • Subjects 18 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • Subjects presenting at the site with normal eyes (eyes without pathology)
  • lOPs 21mmHg bilaterally
  • BCVA 20/40 or better (each eye)
  • Both eyes must be free of eye disease

Exclusion Criteria for Normal Group

  • Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
  • Subjects unable to tolerate ophthalmic imaging
  • Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  • HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD 33% or false positives > 25%, or false negatives > 25%
  • Presence of any ocular pathology except for cataract
  • Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning
  • Narrow angle
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Glaucoma Group

  • Subjects 18 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • Subjects presenting at the site with glaucoma
  • BCVA 20/40 or better in the study eye
  • HFA visual field (24-2 Sita Standard, white on white) result abnormal, defined as GHT 'Outside Normal Limits' and/or PSD 33% or false positives > 25%, or false negatives > 25% in the study eye
  • Presence of any ocular pathology except glaucoma in the study eye
  • Previous ocular surgery or laser treatment, other than uncomplicated refractive procedure or cataract surgery, performed within six months prior to study scanning in the study eye
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine

Inclusion Criteria for Retinal Group

  • Subjects 18 years of age or older on the date of informed consent
  • Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
  • Subjects presenting at the site with retinal disease
  • lOP <= 21mmHg in the study eye
  • BCVA 20/400 or better in the study eye
  • Diagnosis of some type of retinal pathology by investigator, may include, but not limited to: Macular Degeneration, Diabetic Macular Edema, Diabetic Retinopathy, Macular Hole, Epiretinal Membrane, Cystoid Macula Edema, and others

Exclusion Criteria for Retinal Group

  • Subjects that have participated in any previous study using 3D OCT-1 Maestro device.
  • Subjects unable to tolerate ophthalmic imaging
  • Subject with ocular media not sufficiently clear to obtain acceptable OCT images
  • Presence of glaucoma or any ocular pathology other than a Retinal pathology (e.g., cornea pathology) in the study eye
  • Previous ocular surgery or laser treatment other than uncomplicated refractive procedure or cataract surgery performed within six months prior to study scanning in the study eye
  • Narrow angle in the study eye
  • History of leukemia, dementia or multiple sclerosis
  • Concomitant use of hydroxychloroquine and chloroquine
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02277119). 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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