Myopic Macular HaemorrhagesNCT00345228
Myopic Macular Haemorrhages
An observational study of Myopic Macular Haemorrhages, run by Singapore National Eye Centre at 1 site in Singapore.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myopic Macular Haemorrhages
- How many people
- 30 participants
- Where
- 1 siteSingapore
- Study dates
- Jun 2004to Dec 2006
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- High myopia (greater than -6.00DS)
- Macular haemorrhage
Who cannot join
- Macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy
- Allergy to fluorescein or indocyanine green dyes
Trial locations and contacts
1 site in 1 country.
About this study
- To identify the underlying causes of macular haemorrhages in patients with high myopia
- 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
- To study the functional outcome of these eyes as assessed by visual acuity
- To study the morphological outcome of these eyes by clinical assessment (and fundal photography) and fluorescein angiography
Read the 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:
- Patient with myopia (>-6.00DS) presents with loss of central vision
- Examination reveals a macular haemorrhage
- Investigations
- Refraction
- Axial length*
- Fundus fluorescein angiography
- Indocyanine green angiography*
- Determine if a myopic CNV is present or absent
- Management of patient: Treatment vs No treatment
- Treatment being
- Conventional laser
- PDT
- Review at 6 months
- BCVA
- Clinical appearance (fundal photo)
- FFA
- Review at 12 months
- BCVA
- Clinical appearance
- Conditions
- Myopic Macular Haemorrhages
- Keywords
- High myopia, Choroidal neovascularisation, Lacquer crack, Fundus fluorescein angiography, Indocyanine green angiography, Axial length
- Medical subject headings
- Choroidal Neovascularization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2006 (estimated)
- Study startJun 2004
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myopic Macular HaemorrhagesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Defined population
- Time perspective
- Other
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- Singapore National Eye Centre
- Sponsor type
- Other government
- Investigators
- Shu-Yen Lee, FRCSEd, Principal investigator, Singapore National Eye CentreChong-Lye Ang, FRCOphth, Study chair, Singapore National Eye Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345228
- Sponsor's protocol ID
- R347/05/2004
- Status last verified
- May 2004
- First submitted
- 26 Jun 2006
- Last updated
- 27 Jun 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myopic Macular Haemorrhages
- ClinicalTrials.gov ID
- NCT00345228
- Acronym / sponsor ID
- R347/05/2004
- Conditions
- Myopic Macular Haemorrhages
- Keywords
- High myopia, Choroidal neovascularisation, Lacquer crack, Fundus fluorescein angiography, Indocyanine green angiography, Axial length
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- Singapore National Eye CentreOther government
- Study start
- Jun 2004
- Study completion
- Dec 2006
- First posted
- 27 Jun 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- To identify the underlying causes of macular haemorrhages in patients with high myopia
- 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
- To study the functional outcome of these eyes as assessed by visual acuity
- 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:
- Patient with myopia (>-6.00DS) presents with loss of central vision
- Examination reveals a macular haemorrhage
- Investigations
- Refraction
- Axial length*
- Fundus fluorescein angiography
- Indocyanine green angiography*
- Determine if a myopic CNV is present or absent
- Management of patient: Treatment vs No treatment
- Treatment being
- Conventional laser
- PDT
- Review at 6 months
- BCVA
- Clinical appearance (fundal photo)
- FFA
- Review at 12 months
- BCVA
- Clinical appearance
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- High myopia (greater than -6.00DS)
- Macular haemorrhage
Key exclusion criteria (2 listed)
- Macular haemorrhages from other causes eg. diabetic retinopathy, hypertensive retinopathy
- Allergy to fluorescein or indocyanine green dyes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2006.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shu-Yen Lee, FRCSEd principal investigator
Singapore National Eye Centre
Chong-Lye Ang, FRCOphth study chair
Singapore National Eye Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myopic Macular Haemorrhages, run by Singapore National Eye Centre at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2006.