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
1 other identifier
observational
119
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 22, 2014
CompletedFirst Posted
Study publicly available on registry
January 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedSeptember 29, 2014
September 1, 2014
5 months
January 22, 2014
September 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Retinal thickness
Time frame is the maximum duration of hospital stay
Approximately four hours
Optic Disc Analysis
Time frame is the maximum duration of hospital stay
Approximately four hours
Corneal Thickness
Time frame is the maximum duration of hospital stay
Approximately four hours
Study Arms (4)
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 Criteria
Clinic subjects, general population
You may qualify if:
- Subjects who do not have pathology in both eyes
- Subjects who have a glaucoma diagnosis
- Subjects who have a retinal diagnosis including but not limited to:
- Diabetic macular edema
- Dry age related macular degeneration
- Wet age related macular degeneration
- Cystoid macular edema
- Epiretinal membrane
- Macular hole
- Subjects who has one of these diagnosis:
- Post status LASIK surgery
- Keratoconus
- Other corneal dystrophies or degenerations.
You may not qualify if:
- Subjects who have any of the following conditions
- Diabetes mellitus (DM) and/or diabetic retinopathy
- Uncontrolled Hypertension (HT)
- Cerebral infarction, cerebral hemorrhage, cranial nerve neoplasm and other central nervous system diseases affecting vision
- Cardiac, hepatic, renal and hematologic diseases
- A current condition requiring systemic administration of steroid
- A history of, or currently receiving, anticancer therapy
- Epileptic seizures which are optically induced
- Dementia
- Subjects who have other life threatening and debilitating systemic diseases
- Note: Additional criteria may apply
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nidek Co. LTD.lead
Study Sites (1)
WCCT Global Opthalmology Research Center
Santa Ana, California, 92705, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 22, 2014
First Posted
January 31, 2014
Study Start
January 1, 2014
Primary Completion
June 1, 2014
Study Completion
June 1, 2014
Last Updated
September 29, 2014
Record last verified: 2014-09