NCT03244007

Brief Summary

We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 12, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 11, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 11, 2017

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 9, 2017

Completed
Last Updated

February 20, 2019

Status Verified

February 1, 2019

Enrollment Period

1 year

First QC Date

August 5, 2017

Last Update Submit

February 19, 2019

Conditions

Macular Disease

Keywords

macular holelamellar macular hole

Outcome Measures

Primary Outcomes (1)

  • Recovery of microstructure

    6 months

Secondary Outcomes (1)

  • Visual improvement

    6 months

Study Arms (2)

Eyes with residual fragment

The eyes with residual fragments detected with intraoperative optical coherence tomography

Procedure: Vitrectomy

Eyes without residual fragment

The eyes without residual fragments detected with intraoperative optical coherence tomography

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE
Eyes with residual fragmentEyes without residual fragment

Eligibility Criteria

Age20 Years - 90 Years
Sexall(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The eyes with macular hole or lamellar macular hole

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makoto Inoue

Mitaka-shi, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Macular DegenerationRetinal Perforations

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Makoto Inoue, MD

    Korin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

August 5, 2017

First Posted

August 9, 2017

Study Start

December 12, 2015

Primary Completion

December 11, 2016

Study Completion

June 11, 2017

Last Updated

February 20, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)