Myopic Macular Haemorrhages

Myopic Macular Haemorrhages Clinical Trial

Official title:

Myopic Macular Haemorrhages

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00345228
• Other study ID #: R347/05/2004
• Status: Completed
• Phase: N/A
• First received: June 26, 2006
• Last updated: June 26, 2006
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: May 2004
• Source: Singapore National Eye Centre
• Contact: n/a
• Is FDA regulated: No
• Health authority: Singapore: Domain Specific Review Boards
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Defined Population, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hemorrhage
• Myopia
• Myopic Macular Haemorrhages

Locations

Country	Name	City	State
Singapore	Singapore National Eye Centre	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
Singapore National Eye Centre

Country where clinical trial is conducted

Singapore,