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OCT Agreement and Crossed Precision Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Nidek Co. LTD.
ClinicalTrials.gov Identifier:
NCT02050880
First received: January 22, 2014
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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.


Condition
Glaucoma
Retinal Disease
Corneal Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Nidek Co. LTD.:

Primary Outcome Measures:
  • 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


Enrollment: 119
Study Start Date: January 2014
Study Completion Date: June 2014
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Normal eyes
Eyes without pathology.
Glaucoma
Eyes with Glaucoma.
Retinal
Eyes with Retinal Disease.
Corneal
Eyes with corneal disease including a kerato-refractive group.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Clinic subjects, general population

Criteria

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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02050880

Locations
United States, California
WCCT Global Opthalmology Research Center
Santa Ana, California, United States, 92705
Sponsors and Collaborators
Nidek Co. LTD.
  More Information

No publications provided

Responsible Party: Nidek Co. LTD.
ClinicalTrials.gov Identifier: NCT02050880     History of Changes
Other Study ID Numbers: RS-3000 series Protocol 1
Study First Received: January 22, 2014
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Nidek Co. LTD.:
Normal Eyes
Eye; Disorder with Glaucoma
Eye; Disorder with Retinal Disease
Eye; Disorder Corneal Disease incl kerato-refractive group

Additional relevant MeSH terms:
Corneal Diseases
Glaucoma
Retinal Diseases
Eye Diseases
Ocular Hypertension

ClinicalTrials.gov processed this record on November 19, 2014