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

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.

Study Overview

• Status: Completed
• Conditions: Macular Holes
• Intervention / Treatment: Other: vitrectimy

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 Type: Observational
• Enrollment (Actual): 100

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Japanese

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
macular hole without vitreomacular tracation; Vitrectomy	Other: vitrectimy; Clinical characteristics and surgical outcomes
Stage 2 macular hole with vitreomacular tracation; Vitrectomy	Other: vitrectimy; Clinical characteristics and surgical outcomes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative visual acuity	logMAR visual acuity	1month, 3, 6 and 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
postoperative status of outer retinal layer in OCT B-scan images	External limiting mambrane, Elipsoid zone, Interdegitaion zone	1month, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: St. Marianna University School of Medicine
• Collaborators: University of Toyama; Takaoka city Hospital
• Investigators: Principal Investigator: Jiro Kogo, MD PhD, Akita University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2016
• Primary Completion (Actual): March 31, 2024
• Study Completion (Actual): July 31, 2024

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 16, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): August 19, 2024
• Last Update Submitted That Met QC Criteria: August 16, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: vitrectomy; macular hole; epiretinal prolidferation
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: MariannaU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No