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

Completed

• Conditions: Macular Holes
• Interventions: Other: vitrectimy

• Registration Number: NCT06560710
• Lead Sponsor: St. Marianna University School of Medicine

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.

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 Timeline

• Study Start: 2016-12-01
• Primary Completion: 2024-03-31
• Study Completion: 2024-07-31
• Status Verified: 2024-08
• Study First Submitted: 2024-08-14
• Study First Submitted QC: 2024-08-16
• Last Update Submitted: 2024-08-16
• Study First Posted: 2024-08-19
• Last Update Posted: 2024-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• macular hole without posterior vitreous detachment at the fovea

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
macular hole without vitreomacular tracation	vitrectimy	Vitrectomy
Stage 2 macular hole with vitreomacular tracation	vitrectimy	Vitrectomy

Primary Outcome Measures

Name	Time	Method
postoperative visual acuity	1month, 3, 6 and 12 months	logMAR visual acuity

Secondary Outcome Measures

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