Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345228
Status:
COMPLETED
Last Update Posted:
2006-06-27
First Post:
2006-06-26
Brief Title:
Myopic Macular Haemorrhages
Sponsor:
Singapore National Eye Centre
Organization:
Singapore National Eye Centre
Study Overview
Official Title:
Myopic Macular Haemorrhages
Status:
COMPLETED
Status Verified Date:
2004-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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:
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 -600DS 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
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 -600DS 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None