NCT01959776

Brief Summary

Evaluation of asymmetry in recovery of cone outer segment tips and foveal displacement after macular hole surgery

Trial Health

87
On Track

Trial Health Score

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

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2009

Typical duration 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

July 1, 2009

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
2.7 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 Hole

Keywords

cone outer segment tips line, foveal displacement

Outcome Measures

Primary Outcomes (1)

  • Optical coherence tomography

    Anatomical evaluation detected with optical coherence tomography after surgical intervention

    one year

Secondary Outcomes (1)

  • Visual recovery

    one year

Study Arms (1)

Vitrectomy

OTHER
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 patients with macular 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

Related Publications (1)

  • Itoh Y, Inoue M, Rii T, Ando Y, Hirakata A. Asymmetrical recovery of cone outer segment tips line and foveal displacement after successful macular hole surgery. Invest Ophthalmol Vis Sci. 2014 May 6;55(5):3003-11. doi: 10.1167/iovs.14-13973.

    PMID: 24736052DERIVED

MeSH Terms

Conditions

Retinal Perforations

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
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

July 1, 2009

Primary Completion

July 1, 2009

Study Completion

March 1, 2012

Last Updated

October 10, 2013

Record last verified: 2013-10

Locations

JP(1)