Clincosm LogoSign in Get a demo

Macular Hemorrhage in Myopic Eyes

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01943448
Collaborator
(none)
30
Enrollment
1
Location
21
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Macular Hemorrhage in Myopic Eyes
    Study Start Date :
    Aug 1, 2013
    Anticipated Primary Completion Date :
    May 1, 2015
    Anticipated Study Completion Date :
    May 1, 2015

    Outcome Measures

    Primary Outcome Measures

    1. visual acuity [1 year]

      visual acuity during follow up and its correlation to other factors

    Secondary Outcome Measures

    1. Optical coherence tomography [1 year]

      Change of microstructure of the retina and choroid on OCT during follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Ophthalmology, National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Tzyy-Chang Ho, MD, National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT01943448
    Other Study ID Numbers:
    • 201303121RINC
    First Posted:
    Sep 17, 2013
    Last Update Posted:
    Apr 15, 2014
    Last Verified:
    Apr 1, 2014
    Keywords provided by National Taiwan University Hospital
    Macula Lutea Hemorrhage
    High Myopia
    Optical Coherence Tomography
    Additional relevant MeSH terms:
    Myopia
    Hemorrhage

    Study Results

    No Results Posted as of Apr 15, 2014