Eye InjuriesNCT02638025
Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
An observational study of Eye Injuries, run by Huizhou Municipal Central Hospital.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Eye Injuries
- What is being tested?
- OCT
- Type of treatment
- Medical device
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Jan 2010to Jul 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume
Who cannot join
- can not cooperate with examination
About this study
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.
Read the 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.
- Conditions
- Eye Injuries
- Being tested
- OCT
- Medical subject headings
- Eye Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCTDevice
Anterior Segment Spectral-domain Optical Coherence Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
anterior segment spectral-domain optical coherence tomography (SD-OCT) findings in patients with closed globe injury
Measured: within 24 hours after patients were admitted
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2015 (estimated)
- Study startJan 2010
- Primary completionJul 2011
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huizhou Municipal Central Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02638025
- Sponsor's protocol ID
- HMCH20151216
- Status last verified
- Dec 2015
- First submitted
- 16 Dec 2015
- Last updated
- 22 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Anterior Segment Spectral-domain Optical Coherence Tomography in Patients With Closed Globe Injury
- ClinicalTrials.gov ID
- NCT02638025
- Acronym / sponsor ID
- HMCH20151216
- Conditions
- Eye Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Huizhou Municipal Central HospitalUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 22 Dec 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- patients with closed globe injury were recruited; had hyphema at least 1/3 of anterior chamber volume
Key exclusion criteria (1 listed)
- can not cooperate with examination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCTAnterior Segment Spectral-domain Optical Coherence Tomography | Device | – |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Eye Injuries, run by Huizhou Municipal Central Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2015.