NCT02896972

Brief Summary

To evaluate efficacy of vitrectomy with inverted internal limiting membrane (ILM) flap technique for macular hole retinal detachment (MHRD) in highly myopic eyes, and to demonstrate postoperative clinical course of MHRD after inverted ILM flap technique using swept-source optical coherence tomography (OCT)

Trial Health

100
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2012

Longer than P75 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

September 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 12, 2016

Completed
Last Updated

January 10, 2017

Status Verified

January 1, 2017

Enrollment Period

3.9 years

First QC Date

September 7, 2016

Last Update Submit

January 9, 2017

Conditions

Macular Hole Retinal Detachment

Keywords

vitrectomymacular hole retinal detachmenthigh myopia

Outcome Measures

Primary Outcomes (1)

  • Visual acuity before and after surgery

    Changes from baseline to 1, 3, 6 months

Secondary Outcomes (1)

  • Optical coherence tomography

    Changes from baseline up to 6 months

Study Arms (2)

Inverted ILM flap group

ACTIVE COMPARATOR

Eyes underwent vitrectomy with inverted internal limiting membrane technique

Procedure: Vitrectomy

ILM peeling group

ACTIVE COMPARATOR

Eyes underwent vitrectomy with internal limiting membrane peeling

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

Vitrectomy with inverted ILM technique or ILM peeling

ILM peeling groupInverted ILM flap group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • The patients with follow-up less than 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

September 7, 2016

First Posted

September 12, 2016

Study Start

April 1, 2012

Primary Completion

March 1, 2016

Study Completion

September 1, 2016

Last Updated

January 10, 2017

Record last verified: 2017-01