NCT01959802

Brief Summary

Evaluation of recovery in foveal cone outer segment tips line defect and visual acuity after surgery for macular pseudohole

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Apr 2008

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, 2008

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2012

Completed
1.6 years 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

Same day

First QC Date

October 7, 2013

Last Update Submit

October 8, 2013

Conditions

Macular Psudohole

Keywords

Macular pseudoholeCone outer segment tips line

Outcome Measures

Primary Outcomes (1)

  • Optical coherence tomography

    Anatomical recovery detected with optical coherence tomography after surgery

    one year

Secondary Outcomes (1)

  • Visual acuity

    one year

Study Arms (1)

Vitrectomy

OTHER

Vitrectomy for macular pseudo hole

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE
Vitrectomy

Eligibility Criteria

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

You may qualify if:

  • The patienst with macular pseudo hole

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)

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
NON RANDOMIZED
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, 2008

Primary Completion

April 1, 2008

Study Completion

March 1, 2012

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

JP(1)