Macula Lutea HemorrhageNCT01943448
Macular Hemorrhage in Myopic Eyes
An observational study of Macula Lutea Hemorrhage and High Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Visual impairment in high myopic eyes is mainly due to the different types of myopic maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal neovascularization. Macular hemorrhage was one of those complications. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Macula Lutea Hemorrhage, High Myopia
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2013to May 2015
- How long will I take part?
- 2 Years
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Myopia more than -6D 2. Macular hemorrhage inside arcade 3. Patients who are willing to visit our clinic and receive examination regularly for at least 1 year
Who may be able to join
- Myopia more than -6D
- Macular hemorrhage inside arcade
- Patients who are willing to visit our clinic and receive examination regularly for at least 1 year
Who cannot join
- Patients who cannot cooperate.
- Macular hemorrhage unrelated to myopia
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Department of Ophthalmology, National Taiwan University Hospital
Taipei, 100
Tzyy-Chang Ho, MD, 886-2-23123456 ext. 62579, hotc@ntuh.gov.tw
Ting-Yu Wu, MD, 886-2-23123456 ext. 62580, b89401001@ntu.edu.tw
About this study
Visual impairment in high myopic eyes is mainly due to the different types of myopic maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal neovascularization. Macular hemorrhage was one of those complications. Despite choroidal neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple hemorrhage is generally good. However, some patients had persistently poor vision after the absorption of the hemorrhage. In the literature, the visual prognosis in those patients was reported to be associated with the microstructure change under the optical coherent tomography (OCT) or the presentation of the autofluorescence. The investigators will collect the patients with high myopia and presenting with macular hemorrhage. High resolution OCT and autofluorescence imaging will be used to analyze the change of the microstructure of retina and its correlation with the visual prognosis.
- Conditions
- Macula Lutea Hemorrhage, High Myopia
- Keywords
- Macula Lutea Hemorrhage, High Myopia, Optical Coherence Tomography
What is being measured
The primary outcome is the main question the study is designed to answer.
visual acuity
visual acuity during follow up and its correlation to other factors
Measured: 1 year
Secondary outcomes (1)
Optical coherence tomography
Change of microstructure of the retina and choroid on OCT during follow up
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionMay 2015 (estimated)
- Study completionMay 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macula Lutea HemorrhageStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- 30 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tzyy-Chang Ho, MD, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943448
- Sponsor's protocol ID
- 201303121RINC
- Status last verified
- Apr 2014
- First submitted
- 12 Sep 2013
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Macular Hemorrhage in Myopic Eyes
- ClinicalTrials.gov ID
- NCT01943448
- Acronym / sponsor ID
- 201303121RINC
- Conditions
- Macula Lutea Hemorrhage, High Myopia
- Keywords
- Macula Lutea Hemorrhage, High Myopia, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- May 2015 (estimated)
- Study completion
- May 2015 (estimated)
- First posted
- 17 Sep 2013 (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.
Visual impairment in high myopic eyes is mainly due to the different types of myopic maculopathies, such as diffuse or patchy atrophy, lacquer cracks and choroidal neovascularization. Macular hemorrhage was one of those complications. Despite choroidal neovascularization, simple hemorrhage from rupture of Bruch's membrane and choroidal microcirculation is also the cause of hemorrhage. The prognosis of those eyes with simple hemorrhage is generally good. However, some patients had persistently poor vision after the absorption of the hemorrhage. In the literature, the visual prognosis in those patients was reported to be associated with the microstructure change under the optical coherent tomography (OCT) or the presentation of the autofluorescence. The investigators will collect the patients with high myopia and presenting with macular hemorrhage. High resolution OCT and autofluorescence imaging will be used to analyze the change of the microstructure of retina and its correlation with the visual prognosis.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Myopia more than -6D 2. Macular hemorrhage inside arcade 3. Patients who are willing to visit our clinic and receive examination regularly for at least 1 year
Key inclusion criteria (3 listed)
- Myopia more than -6D
- Macular hemorrhage inside arcade
- Patients who are willing to visit our clinic and receive examination regularly for at least 1 year
Key exclusion criteria (2 listed)
- Patients who cannot cooperate.
- Macular hemorrhage unrelated to myopia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
visual acuity
Time frame: 1 year
visual acuity during follow up and its correlation to other factors
1 secondary outcome
Optical coherence tomography
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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.
Department of Ophthalmology, National Taiwan University Hospital
Taipei, Taiwan
Tzyy-Chang Ho, MD principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macula Lutea Hemorrhage and High Myopia, run by National Taiwan University Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visual acuity (time frame: 1 year). 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 15 Apr 2014.