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

NCT ID: NCT06560710

Last Updated: 2024-08-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-12-01

Study Completion Date

2024-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Macular Holes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

macular hole without vitreomacular tracation

Vitrectomy

vitrectimy

Intervention Type OTHER

Clinical characteristics and surgical outcomes

Stage 2 macular hole with vitreomacular tracation

Vitrectomy

vitrectimy

Intervention Type OTHER

Clinical characteristics and surgical outcomes

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

vitrectimy

Clinical characteristics and surgical outcomes

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

\- macular hole without posterior vitreous detachment at the fovea

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
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Toyama

OTHER

Sponsor Role collaborator

Takaoka city Hospital

UNKNOWN

Sponsor Role collaborator

St. Marianna University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Jiro Kogo

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Jiro Kogo, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Akita University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

MariannaU

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Macular Hole Reopening
NCT00927628 COMPLETED