Age-Related Macular DegenerationNCT04196049
Removal of Massive Subretinal Organized Blood Clot With Fragmatome
An observational study of Age-Related Macular Degeneration, run by Changhua Christian Hospital at 1 site in Taiwan.
Trial summary
By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could be removed easily. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Age-Related Macular Degeneration
- What is being tested?
- fragmatome
- Type of treatment
- Surgery or procedure
- How many people
- 3 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Jan 2019to 29 Nov 2019
- 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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy
Who may be able to join
- Patients with massive subretinal hemorrhage from age related macular degeneration
- Patients had organized subretinal blood clot were managed by inferior retinectomy.
Who cannot join
- Patients without massive subretinal hemorrhage
- Patients were not age related macular degeneration.
Trial locations and contacts
1 site in 1 country.
About this study
By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could be removed easily.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- fragmatome
- Keywords
- organized blood clot, fragmatome, exudative age related macular denegeration
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fragmatomeProcedure or surgery
Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy. The subretinal organized blood clot was dragged to the preretinal space and removed by fragmatome. The retinal was reattached with perfluorocarbon liquid and laser was applied at the margin of retinectomy. Silicon oil was infused at the end of surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
visual acuity change in logMAR in different time point
Measured: Before operation, 1 weeks after operation, 1 month after operation.
spherical equivalent
spherical power + half of cylinder power
Measured: Before operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2019
- Study start7 Jan 2019
- Primary completion31 Oct 2019
- Study completion29 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changhua Christian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, San Ni Chen, Changhua Christian Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04196049
- Sponsor's protocol ID
- 191203
- Status last verified
- Dec 2019
- First submitted
- 4 Dec 2019
- Last updated
- 12 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Removal of Massive Subretinal Organized Blood Clot With Fragmatome
- ClinicalTrials.gov ID
- NCT04196049
- Acronym / sponsor ID
- 191203
- Conditions
- Age-Related Macular Degeneration
- Keywords
- organized blood clot, fragmatome, exudative age related macular denegeration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Changhua Christian HospitalUniversity, hospital or other
- Study start
- 7 Jan 2019 (actual)
- Primary completion
- 31 Oct 2019 (actual)
- Study completion
- 29 Nov 2019 (actual)
- First posted
- 12 Dec 2019 (actual)
- 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.
By using the ultrasound power delivered by fragmatome, the hard, organized blood clot could be removed easily.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy
Key inclusion criteria (2 listed)
- Patients with massive subretinal hemorrhage from age related macular degeneration
- Patients had organized subretinal blood clot were managed by inferior retinectomy.
Key exclusion criteria (2 listed)
- Patients without massive subretinal hemorrhage
- Patients were not age related macular degeneration.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fragmatomePatients with massive subretinal hemorrhage from age related macular degeneration and organized subretinal blood clot were managed by inferior retinectomy. The subretinal organized blood clot was dragged to the preretinal space and removed by fragmatome. The retinal was reattached with perfluorocarbon liquid and laser was applied at the margin of retinectomy. Silicon oil was infused at the end of surgery. | Procedure or surgery | – |
Primary outcome
Visual acuity
Time frame: Before operation, 1 weeks after operation, 1 month after operation.
visual acuity change in logMAR in different time point
spherical equivalent
Time frame: Before operation
spherical power + half of cylinder power
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 12 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Age-Related Macular Degeneration, run by Changhua Christian Hospital at 1 site in Taiwan.
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 12 Dec 2019. 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 Taiwan. 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.
What does the primary outcome measure?
Visual acuity (time frame: Before operation, 1 weeks after operation, 1 month after operation.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
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 12 Dec 2019.