Optical Coherence Tomography (OCT) Data Collection 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. Identifier: NCT01641835
Recruitment Status : Completed
First Posted : July 17, 2012
Results First Posted : December 19, 2016
Last Update Posted : December 19, 2016
Information provided by (Responsible Party):
Heidelberg Engineering GmbH

Study Type: Observational
Study Design: Observational Model: Case-Only;   Time Perspective: Prospective
Condition: Glaucoma

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
Normals No eye disease.

Participant Flow:   Overall Study
STARTED   303 

  Baseline Characteristics

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
Normals No eye disease.

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

  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

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 text entered.

  More Information

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

Responsible Party: Heidelberg Engineering GmbH Identifier: NCT01641835     History of Changes
Other Study ID Numbers: S-2012-1 NORM-cc
First Submitted: July 13, 2012
First Posted: July 17, 2012
Results First Submitted: August 1, 2014
Results First Posted: December 19, 2016
Last Update Posted: December 19, 2016