Clinical Characteristics and Surgical Outcomes of Full-th... | NCT06560710

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

NCT06560710

Sponsor

St. Marianna University School of Medicine

Status

Completed

Last Update Posted

Aug 19, 2024Actual

Enrollment

100Actual

Phase

Not provided

Conditions

Macular Holes

Interventions

vitrectimy

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 1, 2016Actual

Primary Completion Date

Mar 31, 2024Actual

Completion Date

Jul 31, 2024Actual

First Submitted Date

Aug 14, 2024

First Submission Date that Met QC Criteria

Aug 16, 2024

First Posted Date

Aug 19, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 16, 2024

Last Update Posted Date

Aug 19, 2024Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Jiro Kogo, Associate Professor, St. Marianna University School of MedicinePrincipal Investigator

Lead Sponsor

St. Marianna University School of MedicineOTHER

Collaborators

Name	Class
University of Toyama	OTHER
Takaoka city Hospital	UNKNOWN

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
macular hole without vitreomacular tracation		Vitrectomy	Other: vitrectimy
Stage 2 macular hole with vitreomacular tracation		Vitrectomy	Other: vitrectimy

Interventions

Name	Type	Description	Arm Group Labels	Other Names
vitrectimy	Other	Clinical characteristics and surgical outcomes	Stage 2 macular hole with vitreomacular tracation macular hole without vitreomacular tracation

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

19 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Japanese

Sampling Method

Probability Sample

Name	Affiliation	Role
Jiro Kogo, MD PhD	Akita University	Principal Investigator

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012167	Retinal Perforations

Ancestor Terms

ID	Term
D012164	Retinal Diseases
D005128	Eye Diseases

Browse Leaves

Not provided

Browse Branches

Not provided