OCT Agreement and Crossed Precision Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Nidek Co. LTD.
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.
ClinicalTrials.gov Identifier:
NCT02050880
First received: January 22, 2014
Last updated: January 30, 2014
Last verified: January 2014

January 22, 2014
January 30, 2014
January 2014
June 2014   (final data collection date for primary outcome measure)
  • Retinal thickness [ Time Frame: Approximately four hours ] [ Designated as safety issue: No ]
    Time frame is the maximum duration of hospital stay
  • Optic Disc Analysis [ Time Frame: Approximately four hours ] [ Designated as safety issue: No ]
    Time frame is the maximum duration of hospital stay
  • Corneal Thickness [ Time Frame: Approximately four hours ] [ Designated as safety issue: No ]
    Time frame is the maximum duration of hospital stay
Same as current
Complete list of historical versions of study NCT02050880 on ClinicalTrials.gov Archive Site
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OCT Agreement and Crossed Precision Study
Crossed Precision Design Study of the Nidek Optical Coherence Tomography RS-3000, RS-3000 Lite and RS-3000 Advance for the Measurements of Retinal and RNFL Thickness, Optic Disc Analysis, and Pachymetry

The purpose of this study is to asses the agreement of the RS-3000 Lite and RS-3000 Advance to the RS-3000, assess the crossed precision of each study device and to assess the transference of a reference database from the RS-3000 to the RS-3000 Lite and to the RS-3000 Advance.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

Clinic subjects, general population

  • Glaucoma
  • Retinal Disease
  • Corneal Disease
Not Provided
  • Normal eyes
    Eyes without pathology.
  • Glaucoma
    Eyes with Glaucoma.
  • Retinal
    Eyes with Retinal Disease.
  • Corneal
    Eyes with corneal disease including a kerato-refractive group.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
168
June 2014
June 2014   (final data collection date for primary outcome measure)

Inclusion Criteria: NORMAL EYES

  • Subjects who do not have pathology in both eyes

Inclusion Criteria: GLAUCOMA

  • Subjects who have a glaucoma diagnosis

Inclusion Criteria: RETINAL

  • Subjects who have a retinal diagnosis including but not limited to:

    1. Diabetic macular edema
    2. Dry age related macular degeneration
    3. Wet age related macular degeneration
    4. Cystoid macular edema
    5. Epiretinal membrane
    6. Macular hole

Inclusion Criteria: CORNEAL

  • Subjects who has one of these diagnosis:

    1. Post status LASIK surgery
    2. Keratoconus
    3. Other corneal dystrophies or degenerations.

Exclusion Criteria: ALL EYES

  • Subjects who have any of the following conditions

    1. Diabetes mellitus (DM) and/or diabetic retinopathy
    2. Uncontrolled Hypertension (HT)
    3. Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
    4. Cardiac, hepatic, renal and hematologic diseases
    5. A current condition requiring systemic administration of steroid
    6. A history of, or currently receiving, anticancer therapy
    7. Epileptic seizures which are optically induced
    8. Dementia
  • Subjects who have other life threatening and debilitating systemic diseases

Note: Additional criteria may apply

Both
20 Years and older
Yes
United States
 
NCT02050880
RS-3000 series Protocol 1
No
Nidek Co. LTD.
Nidek Co. LTD.
Not Provided
Not Provided
Nidek Co. LTD.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP