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OpenTrials
Completed

NCT Number: NCT06560710

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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

vitrectimy

Other

Clinical characteristics and surgical outcomes

Primary outcomes

  1. postoperative visual acuity

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

    logMAR visual acuity

Secondary outcomes

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

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

    External limiting mambrane, Elipsoid zone, Interdegitaion zone

Sponsors and collaborators

Lead sponsor

St. Marianna University School of Medicine

Other

Collaborators

  • Takaoka city Hospital
  • University of Toyama

Registry information

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Aug 19, 2024
Registry last updated
Aug 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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