NCT01862627

Brief Summary

Clinical features, optical coherence tomography findings and surgical outcome in eyes with macular retinoschisis and detachment with normal tension glaucoma but without optic disc pit or high myopia were evaluated.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 15, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 24, 2013

Completed
Last Updated

August 20, 2014

Status Verified

August 1, 2014

Enrollment Period

8.3 years

First QC Date

May 15, 2013

Last Update Submit

August 18, 2014

Conditions

Macular RetinoschisisMacular DetachmentNormal Tension Glaucoma

Keywords

Macular retinoschisisMacular detachmentvitrectomy

Outcome Measures

Primary Outcomes (1)

  • Optical coherence tomography

    Anatomical improvement detected with optical coherence tomography after surgical intervention.

    One year

Secondary Outcomes (1)

  • Visual recovery

    One year

Study Arms (1)

Macular retinoschisis and detachment

Procedure: Optical coherence tomography

Interventions

Optical coherence tomographyPROCEDURE
Macular retinoschisis and detachment

Eligibility Criteria

Age10 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The patients with macular retinoschisis and detachment associated with normal tension glaucoma

You may qualify if:

  • The patients with macular retinoschisis and detachment associated with normal tension glaucoma

You may not qualify if:

  • Optic pit maculopathy, high myopia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Low Tension Glaucoma

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

GlaucomaOcular HypertensionEye DiseasesOptic Nerve Diseases

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Officials

  • Makoto Inoue, 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
Associate professor of ophthalmology

Study Record Dates

First Submitted

May 15, 2013

First Posted

May 24, 2013

Study Start

December 1, 2004

Primary Completion

April 1, 2013

Last Updated

August 20, 2014

Record last verified: 2014-08

Locations

JP(1)