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Myopic Macular Haemorrhages

This study has been completed.
Sponsor:
Information provided by:
Singapore National Eye Centre
ClinicalTrials.gov Identifier:
NCT00345228
First received: June 26, 2006
Last updated: NA
Last verified: May 2004
History: No changes posted
  Purpose
  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
Myopic Macular Haemorrhages

Study Type: Observational
Study Design: Observational Model: Defined Population
Observational Model: Natural History
Time Perspective: Cross-Sectional
Time Perspective: Prospective
Official Title: Myopic Macular Haemorrhages

Further study details as provided by Singapore National Eye Centre:

Estimated Enrollment: 30
Study Start Date: June 2004
Estimated Study Completion Date: December 2006
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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00345228     History of Changes
Other Study ID Numbers: R347/05/2004
Study First Received: June 26, 2006
Last Updated: June 26, 2006
Health Authority: Singapore: Domain Specific Review Boards

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
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013