- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943448
Macular Hemorrhage in Myopic Eyes
April 13, 2014 updated by: National Taiwan University Hospital
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 Overview
Status
Unknown
Conditions
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Taipei, Taiwan, 100
- Recruiting
- Department of Ophthalmology, National Taiwan University Hospital
-
Contact:
- Tzyy-Chang Ho, MD
- Phone Number: 62579 886-2-23123456
- Email: hotc@ntuh.gov.tw
-
Contact:
- Ting-Yu Wu, MD
- Phone Number: 62580 886-2-23123456
- Email: b89401001@ntu.edu.tw
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
- 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
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Patients who cannot cooperate.
- Macular hemorrhage unrelated to myopia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
visual acuity
Time Frame: 1 year
|
visual acuity during follow up and its correlation to other factors
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Optical coherence tomography
Time Frame: 1 year
|
Change of microstructure of the retina and choroid on OCT during follow up
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tzyy-Chang Ho, MD, National Taiwan University Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (ANTICIPATED)
May 1, 2015
Study Completion (ANTICIPATED)
May 1, 2015
Study Registration Dates
First Submitted
September 12, 2013
First Submitted That Met QC Criteria
September 16, 2013
First Posted (ESTIMATE)
September 17, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
April 15, 2014
Last Update Submitted That Met QC Criteria
April 13, 2014
Last Verified
April 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 201303121RINC
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on High Myopia
-
Shanghai Eye Disease Prevention and Treatment CenterShanghai General Hospital, Shanghai Jiao Tong University School of MedicineEnrolling by invitationHigh Myopia | Pathologic MyopiaChina
-
Shanghai Eye Disease Prevention and Treatment CenterEssilor InternationalNot yet recruiting
-
Shanghai Eye Disease Prevention and Treatment CenterShanghai General Hospital, Shanghai Jiao Tong University School of Medicine; Shandong University of Traditional Chinese MedicineNot yet recruiting
-
Tianjin Eye HospitalActive, not recruitingMyopia | High MyopiaChina
-
Beijing Tongren HospitalTsinghua UniversityActive, not recruiting
-
Assiut UniversityCompleted
-
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUnknown
-
Instituto de Olhos de GoianiaCompleted