Cirrus HD-OCT Measurement of Area of Increased Light Penetration Under the Retinal Pigment Epithelium (RPE)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier:
NCT01272076
First received: January 5, 2011
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: June 24, 2013  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Conditions: Age Related Macular Degeneration
Geographic Atrophy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
85 subjects were enrolled between 1/10/2011 - 2/25/2011. The study was conducted at Retina Specialist clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment a screening image of the retina is done to ensure that the area of Geographic Atrophy is consistent with the inclusion criteria. We enrolled 85 subjects, however, 19 were determined not to be eligible per study protocol. In addition, images of 14 subjects did not meet predetermined qualification criteria per study protocol.

Reporting Groups
  Description
Dry AMD With Geographic Atrophy Patients diagnosed with dry AMD and geographic atrophy

Participant Flow:   Overall Study
    Dry AMD With Geographic Atrophy  
STARTED     52  
COMPLETED     52  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
GA Group Patients diagnosed with dry AMD and geographic atrophy

Baseline Measures
    GA Group  
Number of Participants  
[units: participants]
  52  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     2  
>=65 years     50  
Age  
[units: years]
Mean ± Standard Deviation
  83.6  ± 6.2  
Gender  
[units: participants]
 
Female     32  
Male     20  
Region of Enrollment  
[units: participants]
 
United States     52  



  Outcome Measures

1.  Primary:   Difference in mm Squared of Cirrus HD-OCT Automated Measurements of the Illumination Areaa Under the RPE to Expert Manual Measurement of Areas of Hypofluorescence Typical of Geographic Atrophy (GA).   [ Time Frame: August 2011 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No adverse event were found or reported for this study.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Carmelina Gordon, MD
Organization: TLC Eyecare and Laser Centers
phone: (517) 7821213
e-mail: shellie.fuentes@tlcmi.com


Publications:

Responsible Party: Carl Zeiss Meditec, Inc.
ClinicalTrials.gov Identifier: NCT01272076     History of Changes
Other Study ID Numbers: HD-OCT-GA-2010-1-v2
Study First Received: January 5, 2011
Results First Received: June 24, 2013
Last Updated: December 17, 2013
Health Authority: United States: Institutional Review Board