NCT02528058

Brief Summary

The excised ILM from 7 eyes of 7 patients with MTM including 7 eyes with macular retinoschisis and 4 eyes with foveal detachment but without any retinal break underwent vitrectomy with induction of posterior vitreous detachment and ILM peeling was examined to evaluate ultrastructure with electron microscopy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2010

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

June 1, 2010

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2015

Completed
Last Updated

August 19, 2015

Status Verified

August 1, 2015

Enrollment Period

4.1 years

First QC Date

August 16, 2015

Last Update Submit

August 17, 2015

Conditions

Myopic Traction Maculopathy

Keywords

Myopic traction maculopathy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity before and after surgery

    Comparison in logarithm of Minimum Angle of Resolution (logMAR) vision

    6 months

Secondary Outcomes (1)

  • Retinal reattachment

    6 months

Study Arms (1)

Myopic traction maculopathy

Procedure: Vitrectomy with internal limiting membrane peeling

Interventions

Vitrectomy with internal limiting membrane peelingPROCEDURE
Myopic traction maculopathy

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The patients who underwent vitrectomy with internal limiting membrane peeling for myopic traction maculopathy

You may not qualify if:

  • The patients with follow-up less than 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makoto Inoue

Mitaka, Tokyo, 181-8611, Japan

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Excised internal limiting membrane during the surgical treatment for myopic traction maculopathy

MeSH Terms

Interventions

Vitrectomy

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Akito Hirakata, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Kyorin Eye Center

Study Record Dates

First Submitted

August 16, 2015

First Posted

August 19, 2015

Study Start

June 1, 2010

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

August 19, 2015

Record last verified: 2015-08

Locations

JP(1)