Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,NCT02081170
The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
A study testing Autologous platelet concentrate in people with Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or, and Large Size Macular Hole (Diameter > 600 Microns) or, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,, Large Size Macular Hole (Diameter > 600 Microns) or, Recurred or Failed Macular Hole From Previous Surgery
- What is being tested?
- Autologous platelet concentrate
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2013to Dec 2014
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Macular hole with any of following condition
- High myopia (spherical equivalent ≤ -6.0 Diopters)
- Large size macular hole (Diameter > 600 microns)
- Recurred or failed macular hole from previous surgery
- Chronic macular hole (symptom duration > 6 months)
Who cannot join
- Systemic infection
- Hematologic disease
- Severe maculopathy including severe diabetic retinopathy, advanced age-related macular degeneration
Trial locations and contacts
1 site in 1 country.
Ga Eun Cho, MD contact
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, Seoul, 0000
Se Woong Kang, MD, +82-2-3410-3562
Ga Eun Cho, MD, +82-2-3410-3548
About this study
The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.
- Conditions
- Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,, Large Size Macular Hole (Diameter > 600 Microns) or, Recurred or Failed Macular Hole From Previous Surgery, or Chronic Macular Hole (Symptom Duration > 6 Months)
- Being tested
- Autologous platelet concentrate
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous platelet concentrateProcedure or surgery
- pars plana vitrectomy
- internal limiting membrane removal
- Fluid-air exchange
- Intravitreal autologous platelet concentrate injection
- Intravitreal gas (14% C3F8) injection
- Keep prone position for 7-14 days after surgery
| Study group | Role | What they receive |
|---|---|---|
| autologous platelet concentrate | Experimental | Not described Receives: Procedure: Autologous platelet concentrate |
What is being measured
The primary outcome is the main question the study is designed to answer.
macular hole closure
Measured: 6 months
Secondary outcomes (3)
best-corrected visual acuity
Measured: 6 months
metamorphopsia score
Measured: 6 months
safety outcome
frequency and severity of ocular adverse event
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2014 (estimated)
- Study startDec 2013
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02081170
- Sponsor's protocol ID
- 2013-12-066
- Status last verified
- Mar 2014
- First submitted
- 5 Mar 2014
- Last updated
- 7 Mar 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Intravitreal Autologous Platelet Concentrate Injection as an Adjunct of Vitrectomy for the Treatment of Refractory Macular Holes
- ClinicalTrials.gov ID
- NCT02081170
- Acronym / sponsor ID
- 2013-12-066
- Conditions
- Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or,, Large Size Macular Hole (Diameter > 600 Microns) or, Recurred or Failed Macular Hole From Previous Surgery, or Chronic Macular Hole (Symptom Duration > 6 Months)
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (estimated)
- First posted
- 7 Mar 2014 (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.
The purpose of this study is to determine the effectiveness of intravitreal autologous platelet concentrate (APC) injection during the surgery for refractory macular holes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| autologous platelet concentrate | Experimental | Procedure: Autologous platelet concentrate |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Macular hole with any of following condition
Key exclusion criteria (3 listed)
- Systemic infection
- Hematologic disease
- Severe maculopathy including severe diabetic retinopathy, advanced 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 |
|---|---|---|
| Autologous platelet concentrate1. pars plana vitrectomy 2. internal limiting membrane removal 3. Fluid-air exchange 4. Intravitreal autologous platelet concentrate injection 5. Intravitreal gas (14% C3F8) injection 6. Keep prone position for 7-14 days after surgery | Procedure or surgery | autologous platelet concentrate |
Primary outcome
macular hole closure
Time frame: 6 months
3 secondary outcomes
best-corrected visual acuity
Time frame: 6 months
metamorphopsia score
Time frame: 6 months
safety outcome
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
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.
Ga Eun Cho, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous platelet concentrate in people with Macular Hole With High Myopia (Spherical Equivalent ≤ -6.0 Diopters) or, and Large Size Macular Hole (Diameter > 600 Microns) or, run by Samsung Medical Center at 1 site in South Korea.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 7 Mar 2014. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ga Eun Cho, MD (+82-3410-3548), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
macular hole closure (time frame: 6 months). 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 7 Mar 2014.