Macular HolesNCT06560710
Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.
An observational study of Macular Holes, run by St. Marianna University School of Medicine.
Trial summary
This multicenter, retrospective, observational comparative study. We occasionally encounter FTMHs in which PVD has not been achieved and VMT is absent. These FTMHs cannot be defined by stage in the Gass1) or IVTS3) classification. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Holes
- What is being tested?
- vitrectimy
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2016to 31 Jul 2024
- 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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Japanese
Who may be able to join
- macular hole without posterior vitreous detachment at the fovea
Who cannot join
- macular hole with posterior vitreous detachment at the fovea
- Stage1.3.4 macular hole
- Macular hole-associated retinal detachment
- Macular hole with subretinal hemorrhage
- Traumatic MH
About this study
This multicenter, retrospective, observational comparative study. We occasionally encounter FTMHs in which PVD has not been achieved and VMT is absent. These FTMHs cannot be defined by stage in the Gass1) or IVTS3) classification. It is not known whether traction is involved in the development of these atypical macular holes, but they are often classified as Gass stage 2 or 3 according to the size of the hole.
The aim of this study was to investigate the clinical features and surgical outcomes of FTMHs without focal VMT and to discuss possible underlying mechanisms.
Read the detailed description
The clinical characteristics and surgical outcomes the patients diagnosed with FTMH without focal VMT in the macula (classified as VMT-) are presented, in addition to a comparative analysis of the patients presenting with classic stage 2 FTMH with focal VMT (classified as VMT+) according to international classification criteria.
- Conditions
- Macular Holes
- Being tested
- vitrectimy
- Keywords
- macular hole, epiretinal prolidferation, vitrectomy
- Medical subject headings
- Retinal Perforations
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitrectimyOther
Clinical characteristics and surgical outcomes
| Study group | Role | What they receive |
|---|---|---|
| macular hole without vitreomacular tracation | Vitrectomy Receives: Other: vitrectimy | |
| Stage 2 macular hole with vitreomacular tracation | Vitrectomy Receives: Other: vitrectimy |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative visual acuity
logMAR visual acuity
Measured: 1month, 3, 6 and 12 months
Secondary outcomes (1)
postoperative status of outer retinal layer in OCT B-scan images
External limiting mambrane, Elipsoid zone, Interdegitaion zone
Measured: 1month, 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2024
- Study start1 Dec 2016
- Primary completion31 Mar 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Marianna University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toyama, Takaoka city Hospital
- Responsible party
- Principal investigator, Jiro Kogo, St. Marianna University School of Medicine
- Investigators
- Jiro Kogo, MD PhD, Principal investigator, Akita University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06560710
- Sponsor's protocol ID
- MariannaU
- Status last verified
- Aug 2024
- First submitted
- 14 Aug 2024
- Last updated
- 19 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.
- ClinicalTrials.gov ID
- NCT06560710
- Acronym / sponsor ID
- MariannaU
- Conditions
- Macular Holes
- Keywords
- macular hole, epiretinal prolidferation, vitrectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- St. Marianna University School of MedicineUniversity, hospital or other
- Collaborators
- University of Toyama, Takaoka city Hospital
- Study start
- 1 Dec 2016 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 19 Aug 2024 (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.
This multicenter, retrospective, observational comparative study. We occasionally encounter FTMHs in which PVD has not been achieved and VMT is absent. These FTMHs cannot be defined by stage in the Gass1) or IVTS3) classification. It is not known whether traction is involved in the development of these atypical macular holes, but they are often classified as Gass stage 2 or 3 according to the size of the hole.
The aim of this study was to investigate the clinical features and surgical outcomes of FTMHs without focal VMT and to discuss possible underlying mechanisms.
Detailed description
The clinical characteristics and surgical outcomes the patients diagnosed with FTMH without focal VMT in the macula (classified as VMT-) are presented, in addition to a comparative analysis of the patients presenting with classic stage 2 FTMH with focal VMT (classified as VMT+) according to international classification criteria.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| macular hole without vitreomacular tracation | – | Other: vitrectimyVitrectomy |
| Stage 2 macular hole with vitreomacular tracation | – | Other: vitrectimyVitrectomy |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Japanese
Key inclusion criteria (1 listed)
- macular hole without posterior vitreous detachment at the fovea
Key exclusion criteria (5 listed)
- macular hole with posterior vitreous detachment at the fovea
- Stage1.3.4 macular hole
- Macular hole-associated retinal detachment
- Macular hole with subretinal hemorrhage
- Traumatic MH
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 |
|---|---|---|
| vitrectimyClinical characteristics and surgical outcomes | Other | Stage 2 macular hole with vitreomacular tracation, macular hole without vitreomacular tracation |
Primary outcome
postoperative visual acuity
Time frame: 1month, 3, 6 and 12 months
logMAR visual acuity
1 secondary outcome
postoperative status of outer retinal layer in OCT B-scan images
Time frame: 1month, 3, 6 and 12 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 19 Aug 2024.
- Individual participant dataSharing planned: No
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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.
Jiro Kogo, MD PhD principal investigator
Akita University
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Holes, run by St. Marianna University School of Medicine.
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 5 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 19 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
postoperative visual acuity (time frame: 1month, 3, 6 and 12 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 19 Aug 2024.