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Trial record 91 of 8464 for:    Ophthalmopathy

iCam Clinical Validation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01600261
Recruitment Status : Completed
First Posted : May 17, 2012
Last Update Posted : June 28, 2012
Sponsor:
Information provided by (Responsible Party):
Optovue

Tracking Information
First Submitted Date May 14, 2012
First Posted Date May 17, 2012
Last Update Posted Date June 28, 2012
Study Start Date April 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 16, 2012)
proportion of clinically useful images [ Time Frame: Day 1 ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01600261 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title iCam Clinical Validation Study
Official Title iCam Clinical Validation Study
Brief Summary Comparison study to assess photo image quality of a new color fundus camera compared to that of a commercially available color fundus camera.
Detailed Description Optovue has developed a new color fundus camera for imaging the eye with up to 45 degree field of view and without the use of dilating drops. The purpose of the study is to compare the image quality of the new camera with that of a commercially available color fundus camera. Consented subjects will undergo a general ophthalmic examination and series of fundus photography exams using the study device and comparison device. Photo image quality will be assessed for determination of clinically usefulness.
Study Type Observational
Study Design Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Study subjects shall be recruited from the practice of the principal investigator (PI).
Condition Eye Disease
Intervention Not Provided
Study Groups/Cohorts eye exam
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 27, 2012)
131
Original Estimated Enrollment
 (submitted: May 16, 2012)
120
Actual Study Completion Date June 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • At least 18 years of age
  • Able and willing to complete the required examination

Exclusion Criteria:

  • Spherical Equivalent outside -12 diopter to +15 diopter
  • Without lens
  • Inability to fixate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01600261
Other Study ID Numbers 200-47425
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Optovue
Study Sponsor Optovue
Collaborators Not Provided
Investigators Not Provided
PRS Account Optovue
Verification Date June 2012