Myopic Macular Haemorrhages

NCT ID: NCT00345228

Last Updated: 2006-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-06-30

Study Completion Date

2006-12-31

Brief Summary

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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

Detailed Description

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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

Conditions

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Myopic Macular Haemorrhages

Keywords

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High myopia Choroidal neovascularisation Lacquer crack Fundus fluorescein angiography Indocyanine green angiography Axial length

Study Design

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Observational Model Type

DEFINED_POPULATION

Study Time Perspective

OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Singapore National Eye Centre

OTHER_GOV

Sponsor Role lead

Principal Investigators

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Shu-Yen Lee, FRCSEd

Role: PRINCIPAL_INVESTIGATOR

Singapore National Eye Centre

Chong-Lye Ang, FRCOphth

Role: STUDY_CHAIR

Singapore National Eye Centre

Locations

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Singapore National Eye Centre

Singapore, , Singapore

Site Status

Countries

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Singapore

Other Identifiers

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R347/05/2004

Identifier Type: -

Identifier Source: org_study_id