NCT01959724

Brief Summary

Evaluation of clinical characteristics and surgical outcome for macular detachment associated with peripapillary intrachoroidal cavitation with or without pathologic myopia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2007

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2013

Completed
Last Updated

October 10, 2013

Status Verified

October 1, 2013

Enrollment Period

5.9 years

First QC Date

October 7, 2013

Last Update Submit

October 8, 2013

Conditions

Macular DetachmentMacular RetinoschisisIntrachoroidal Cavitation

Keywords

Macular detachmentMacular retinoschisisVitrectomy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

    The numbers of the patients with visual recovery after surgical intervention

    one year

Secondary Outcomes (1)

  • Optical coherence tomography

    one year

Study Arms (1)

Vitrectomy

OTHER

Vitreous surgery to treat macular detachment

Other: Vitrectomy

Interventions

VitrectomyOTHER
Vitrectomy

Eligibility Criteria

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

You may qualify if:

  • Eyes with macular detachment or macular retinoschisis

You may not qualify if:

  • Optic pit maculopathy, vitreomacular traction syndrome

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor of Ophthalmology

Study Record Dates

First Submitted

October 7, 2013

First Posted

October 10, 2013

Study Start

April 1, 2007

Primary Completion

March 1, 2013

Study Completion

September 1, 2013

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

JP(1)