NCT03376776

Brief Summary

We evaluated preoperative and postoperative optical coherence tomograpghic images in eyes with full thickness macular hole (FTMH) whether the epiretinal proliferation (EP) was detected and detection of EP was correlated to the visual improvement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
390

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

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

March 1, 2013

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2017

Completed
Last Updated

December 18, 2017

Status Verified

December 1, 2017

Enrollment Period

3.8 years

First QC Date

December 13, 2017

Last Update Submit

December 13, 2017

Conditions

Macular Disease

Keywords

idiopathic macular hole

Outcome Measures

Primary Outcomes (1)

  • Recovery of foveal microstructure

    6 months

Secondary Outcomes (1)

  • Visual improvement

    6 months

Study Arms (2)

Eyes with epiretinal proliferation

The eyes with epiretinal proliferation around the macular hole detected with optical coherence tomography

Procedure: Vitrectomy

Eyes without epiretinal proliferation

The eyes without epiretinal proliferation around the macular hole detected with optical coherence tomography

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE
Eyes with epiretinal proliferationEyes without epiretinal proliferation

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

You may qualify if:

  • Eyes with macular hole

You may not qualify if:

  • Eyes with retinal detachment, retinal vascular disease, glaucoma, proliferative diabetic retinopathy

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 Degeneration

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Makoto Inoue, MD

    Kyorin 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

December 13, 2017

First Posted

December 18, 2017

Study Start

March 1, 2013

Primary Completion

January 1, 2017

Study Completion

December 1, 2017

Last Updated

December 18, 2017

Record last verified: 2017-12

Locations

JP(1)