Myopic Macular Haemorrhages

June 26, 2006 updated by: Singapore National Eye Centre
  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

Study Overview

Status

Completed

Conditions

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

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

  • Singapore
      • Singapore, Singapore, 168751
        • Singapore National Eye Centre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

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

June 1, 2004

Study Completion

December 1, 2006

Study Registration Dates

First Submitted

June 26, 2006

First Submitted That Met QC Criteria

June 26, 2006

First Posted (Estimate)

June 27, 2006

Study Record Updates

Last Update Posted (Estimate)

June 27, 2006

Last Update Submitted That Met QC Criteria

June 26, 2006

Last Verified

May 1, 2004

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R347/05/2004

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.

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