Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
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| ClinicalTrials.gov Identifier: NCT02638025 |
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Recruitment Status :
Completed
First Posted : December 22, 2015
Last Update Posted : December 22, 2015
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Sponsor:
Huizhou Municipal Central Hospital
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 |
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 |
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| 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
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| Study Groups/Cohorts | Not Provided | ||
| Publications * | Not Provided | ||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||
| Recruitment Status | Completed | ||
| Actual Enrollment |
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:
Exclusion Criteria:
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| Sex/Gender |
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| 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 | ||