NCT01658761

Brief Summary

Surgical outcome of vitrectomy for myopic traction maculopathy in highly myopic eyes was evaluated in each stage. Efficacy of internal limiting membrane was also evaluated whether it may improve visual outcome.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1998

Longer than P75 for not_applicable

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

September 1, 1998

Completed
12.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 28, 2012

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 7, 2012

Completed
Last Updated

August 7, 2012

Status Verified

August 1, 2012

Enrollment Period

12.4 years

First QC Date

July 28, 2012

Last Update Submit

August 1, 2012

Conditions

MaculopathyHigh MyopiaSurgery

Keywords

Myopic traction maculopathyvitrectomyinternal limiting membraneRetrospective, case control study

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    Preoperative and postoperative visual acuity

    One year

Secondary Outcomes (1)

  • Optical coherence tomography

    One year

Study Arms (1)

Myopic traction maculopathy

EXPERIMENTAL

The 71 eyes of 64 patients (14 men and 50 women) with myopic traction maculopathy in highly myopic eyes (refractive errors ≤-8.0 diopters and axial length ≥26.0 mm) who underwent vitrectomy were retrospectively reviewed.

Procedure: vitrectomy

Interventions

vitrectomyPROCEDURE

Surgery

Also known as: Myopic traction maculopathy in highly myopic eyes
Myopic traction maculopathy

Eligibility Criteria

Age30 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Eyes with myopic traction maculopathy in highly myopic eyes with refractive errors ≤ -8.0 diopters and axial length ≥ 26.0 mm who underwent vitrectomy

You may not qualify if:

  • Eyes with follow-up less than a year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, 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
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assosiate professor of Ophthalmology

Study Record Dates

First Submitted

July 28, 2012

First Posted

August 7, 2012

Study Start

September 1, 1998

Primary Completion

February 1, 2011

Study Completion

March 1, 2012

Last Updated

August 7, 2012

Record last verified: 2012-08

Locations

JP(1)