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Optical Coherence Tomography (OCT) Data Collection Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier:
NCT01641835
First received: July 13, 2012
Last updated: October 26, 2016
Last verified: September 2016
Results First Received: August 1, 2014  
Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Glaucoma

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Normals No eye disease.

Participant Flow:   Overall Study
    Normals
STARTED   303 
COMPLETED   303 
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.
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Reporting Groups
  Description
Normals No eye disease.

Baseline Measures
   Normals 
Overall Participants Analyzed 
[Units: Participants]
 303 
Age 
[Units: Participants]
Count of Participants
 
<=18 years      0   0.0% 
Between 18 and 65 years      195  64.4% 
>=65 years      108  35.6% 
Gender 
[Units: Participants]
Count of Participants
 
Female      150  49.5% 
Male      153  50.5% 
Race/Ethnicity, Customized [1] 
[Units: Participants]
 303 
[1] Subjects of Caucasian descent


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Primary Endpoints   [ Time Frame: 3 months ]

2.  Primary:   Bruch's Membrane Opening - Minimum Rim Area, Global   [ Time Frame: 3 months ]


  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
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  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 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.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Gerhard Zinser, PhD
Organization: Heidelberg Engineering GmbH
phone: +4962216463 ext 0
e-mail: Contact@HeidelbergEngineering.com



Responsible Party: Heidelberg Engineering GmbH
ClinicalTrials.gov Identifier: NCT01641835     History of Changes
Other Study ID Numbers: S-2012-1 NORM-cc
Study First Received: July 13, 2012
Results First Received: August 1, 2014
Last Updated: October 26, 2016