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NCT01943448 Clinical Trial

Macular Hemorrhage in Myopic Eyes

High Myopia Clinical Trial

Official title:
Macular Hemorrhage in Myopic Eyes

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT01943448
Other study ID # 201303121RINC
Secondary ID
Status Recruiting
Phase N/A
First received September 12, 2013
Last updated April 13, 2014
Start date August 2013
Est. completion date May 2015

Study information
Verified date April 2014
Source National Taiwan University Hospital
Contact n/a
Is FDA regulated No
Health authority Taiwan: Institutional Review Board
Study type Observational [Patient Registry]

Clinical 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. 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility 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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Taiwan Department of Ophthalmology, National Taiwan University Hospital Taipei

Sponsors (1)
Lead Sponsor Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome
Type Measure Description Time frame Safety issue
Primary visual acuity visual acuity during follow up and its correlation to other factors 1 year No
Secondary Optical coherence tomography Change of microstructure of the retina and choroid on OCT during follow up 1 year No
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