Macular DiseaseNCT03376776
Epiretinal Proliferation in Eyes With Full Thickness Macular Hole
An observational study of Macular Disease, run by Kyorin University at 1 site in Japan.
Trial summary
We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Macular Disease
- What is being tested?
- Vitrectomy
- Type of treatment
- Surgery or procedure
- How many people
- 390 participants
- Where
- 1 siteJapan
- Study dates
- Mar 2013to Dec 2017
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The eyes with macular hole
Who may be able to join
- Eyes with macular hole
Who cannot join
- Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy
Trial locations and contacts
1 site in 1 country.
About this study
We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.
Read the detailed description
We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.
- Conditions
- Macular Disease
- Being tested
- Vitrectomy
- Keywords
- idiopathic macular hole
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VitrectomyProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Eyes with epiretinal proliferation | The eyes with epiretinal proliferation around the macular hole detected with optical coherence tomography Receives: Procedure: Vitrectomy | |
| Eyes without epiretinal proliferation | The eyes without epiretinal proliferation around the macular hole detected with optical coherence tomography Receives: Procedure: Vitrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of foveal microstructure
Measured: 6 months
Secondary outcomes (1)
Visual improvement
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 posted18 Dec 2017
- Study startMar 2013
- Primary completionJan 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular DiseaseStudies 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-control
- Time perspective
- Retrospective
- Enrolment
- 390 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyorin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Makoto Inoue, Kyorin University
- Investigators
- Makoto Inoue, MD, Principal investigator, Kyorin Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376776
- Sponsor's protocol ID
- Kyorineye024
- Status last verified
- Dec 2017
- First submitted
- 13 Dec 2017
- Last updated
- 18 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epiretinal Proliferation in Eyes With Full Thickness Macular Hole
- ClinicalTrials.gov ID
- NCT03376776
- Acronym / sponsor ID
- Kyorineye024
- Conditions
- Macular Disease
- Keywords
- idiopathic macular hole
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 390 participants (actual)
- Lead sponsor
- Kyorin UniversityUniversity, hospital or other
- Study start
- Mar 2013 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 18 Dec 2017 (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.
We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.
Detailed description
We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eyes with epiretinal proliferation | – | Procedure: VitrectomyThe eyes with epiretinal proliferation around the macular hole detected with optical coherence tomography |
| Eyes without epiretinal proliferation | – | Procedure: VitrectomyThe eyes without epiretinal proliferation around the macular hole detected with optical coherence tomography |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The eyes with macular hole
Key inclusion criteria (1 listed)
- Eyes with macular hole
Key exclusion criteria (1 listed)
- Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy
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 |
|---|---|---|
| Vitrectomy | Procedure or surgery | Eyes with epiretinal proliferation, Eyes without epiretinal proliferation |
Primary outcome
Recovery of foveal microstructure
Time frame: 6 months
1 secondary outcome
Visual improvement
Time frame: 6 months
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 18 Dec 2017.
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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.
Makoto Inoue, MD principal investigator
Kyorin Eye Center
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 Macular Disease, run by Kyorin University at 1 site in Japan.
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 1 inclusion and 1 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 18 Dec 2017. 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 Japan. 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?
Recovery of foveal microstructure (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 18 Dec 2017.