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Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury

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ClinicalTrials.gov Identifier: NCT02638025
Recruitment Status : Completed
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
Sponsor:
Information provided by (Responsible Party):
Huizhou Municipal Central Hospital

Tracking Information
First Submitted Date December 16, 2015
First Posted Date December 22, 2015
Last Update Posted Date December 22, 2015
Study Start Date January 2010
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 20, 2015)
anterior segment spectral-domain optical coherence tomography (SD-OCT) findings in patients with closed globe injury [ Time Frame: within 24 hours after patients were admitted ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
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 Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
Official Title Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
Brief Summary This study use anterior segment spectral-domain optical coherence tomography (SD-OCT) to exam patients with closed globe injury, and compared with slit lamp examination. The results showed that OCT can identify features of closed globe injury that were otherwise not visible on slit lamp biomicroscopy.
Detailed Description The anterior segment architecture changes of closed globe injury patients include corneal damage, hyphema, angle recession and lens dislocation, which can be showed with OCT. OCT was superior to slit lamp biomicroscopy examination in detecting anterior segment architecture changes, especially in the presence of media opacities.
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with closed globe injury were recruited, and all eyes of recruited patients had hyphema occupying at least 1/3rd of anterior chamber volume
Condition Eye Injuries
Intervention Device: OCT
Anterior Segment Spectral-domain Optical Coherence Tomography
Study Groups/Cohorts Not Provided
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: December 20, 2015)
16
Original Actual Enrollment Same as current
Actual Study Completion Date July 2015
Actual Primary Completion Date July 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume

Exclusion Criteria:

  • can not cooperate with examination
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT02638025
Other Study ID Numbers HMCH20151216
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Huizhou Municipal Central Hospital
Study Sponsor Huizhou Municipal Central Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Huizhou Municipal Central Hospital
Verification Date December 2015