NCT06560710

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2016

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
7.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2024

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

August 14, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 19, 2024

Completed
Last Updated

August 19, 2024

Status Verified

August 1, 2024

Enrollment Period

7.3 years

First QC Date

August 14, 2024

Last Update Submit

August 16, 2024

Conditions

Macular Holes

Keywords

macular holeepiretinal prolidferationvitrectomy

Outcome Measures

Primary Outcomes (1)

  • postoperative visual acuity

    logMAR visual acuity

    1month, 3, 6 and 12 months

Secondary Outcomes (1)

  • postoperative status of outer retinal layer in OCT B-scan images

    1month, 3, 6 and 12 months

Study Arms (2)

macular hole without vitreomacular tracation

Vitrectomy

Other: vitrectimy

Stage 2 macular hole with vitreomacular tracation

Vitrectomy

Other: vitrectimy

Interventions

vitrectimyOTHER

Clinical characteristics and surgical outcomes

Stage 2 macular hole with vitreomacular tracationmacular hole without vitreomacular tracation

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Japanese

You may qualify if:

  • \- macular hole without posterior vitreous detachment at the fovea

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Jiro Kogo, MD PhD

    Akita University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

August 14, 2024

First Posted

August 19, 2024

Study Start

December 1, 2016

Primary Completion

March 31, 2024

Study Completion

July 31, 2024

Last Updated

August 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share