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CompletedNCT06560710Updated Aug 19, 2024

Clinical Characteristics and Surgical Outcomes of Full-thickness Macular Hole Without Focal Vitreomacular Traction.

An observational study in Macular Holes, sponsored by St. Marianna University School of Medicine. Completed. Open to participants aged 19 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-19.

Sponsored by St. Marianna University School of Medicine · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
100
Ages
19 Years and older
Sex
All
01

Study 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. 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.

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Conditions studied

  • Macular Holes

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Keywords

  • macular hole
  • epiretinal prolidferation
  • vitrectomy
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In context

Retinal Perforations

139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.

This study's enrollment of 100 is above the median of 50 across 43 observational studies indexed under Retinal Perforations.

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Lead sponsor

St. Marianna University School of Medicine is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Japanese

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • macular hole without posterior vitreous detachment at the fovea

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
100 participants (actual)
Patient registry
No

Groups and cohorts

  • macular hole without vitreomacular tracation

    Vitrectomy

    Other: vitrectimy

  • Stage 2 macular hole with vitreomacular tracation

    Vitrectomy

    Other: vitrectimy

Interventions

  • Othervitrectimy

    Clinical characteristics and surgical outcomes

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What researchers measure

Primary outcomes

  1. postoperative visual acuity

    logMAR visual acuity

    Time frame: 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

    Time frame: 1month, 3, 6 and 12 months

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Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06560710
Lead sponsor
St. Marianna University School of Medicine
Collaborators
University of Toyama, Takaoka city Hospital
Responsible party
Jiro Kogo (Associate Professor, St. Marianna University School of Medicine) — Principal investigator
First posted
Aug 19, 2024
Start date
Dec 1, 2016
Primary completion
Mar 31, 2024
Completion
Jul 31, 2024
Last update
Aug 19, 2024

Study contacts

Jiro Kogo, MD PhD
principal investigator · Akita University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.

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