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Myopic Macular Haemorrhages

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ClinicalTrials.gov Identifier: NCT00345228
Recruitment Status : Completed
First Posted : June 27, 2006
Last Update Posted : June 27, 2006
Sponsor:
Information provided by:
Singapore National Eye Centre

Brief Summary:
  1. To identify the underlying causes of macular haemorrhages in patients with high myopia
  2. In the eyes found to have macular haemorrhages secondary to choroidal neovascularisation, we hope to identify the risk factors for the development of choroidal neovascularisation in high myopia
  3. To study the functional outcome of these eyes as assessed by visual acuity
  4. To study the morphological outcome of these eyes by clinical assessment (and fundal photography) and fluorescein angiography

Condition or disease
Myopic Macular Haemorrhages

Detailed Description:

Primary Aims

  • To identify the underlying aetiologies of macular haemorrhages in myopic eyes
  • To study the functional and morphological outcome of these eyes with macular haemorrhages 6 months later Secondary Aims
  • To study the subgroup of eyes with myopic choroidal neovascularisation (CNV), in particular the risk factors for CNV in myopes
  • To study the subgroup of eyes with macular haemorrhages in the absence of CNV

Plan of investigation:

  1. Patient with myopia (>-6.00DS) presents with loss of central vision
  2. Examination reveals a macular haemorrhage
  3. Investigations

    • Refraction
    • Axial length*
    • Fundus fluorescein angiography
    • Indocyanine green angiography*
  4. Determine if a myopic CNV is present or absent
  5. Management of patient: Treatment vs No treatment

    • Treatment being

      1. Conventional laser
      2. PDT
  6. Review at 6 months

    • BCVA
    • Clinical appearance (fundal photo)
    • FFA
  7. Review at 12 months

    • BCVA
    • Clinical appearance

Study Type : Observational
Enrollment : 30 participants
Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Myopic Macular Haemorrhages
Study Start Date : June 2004
Study Completion Date : December 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Eye Care
U.S. FDA Resources





Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High myopia (greater than -6.00DS)
  • Macular haemorrhage

Exclusion Criteria:

  • Macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy
  • Allergy to fluorescein or indocyanine green dyes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00345228


Locations
Singapore
Singapore National Eye Centre
Singapore, Singapore, 168751
Sponsors and Collaborators
Singapore National Eye Centre
Investigators
Principal Investigator: Shu-Yen Lee, FRCSEd Singapore National Eye Centre
Study Chair: Chong-Lye Ang, FRCOphth Singapore National Eye Centre

ClinicalTrials.gov Identifier: NCT00345228     History of Changes
Other Study ID Numbers: R347/05/2004
First Posted: June 27, 2006    Key Record Dates
Last Update Posted: June 27, 2006
Last Verified: May 2004

Keywords provided by Singapore National Eye Centre:
High myopia
Choroidal neovascularisation
Lacquer crack
Fundus fluorescein angiography
Indocyanine green angiography
Axial length

Additional relevant MeSH terms:
Hemorrhage
Myopia
Pathologic Processes
Refractive Errors
Eye Diseases