NCT01306487

Brief Summary

The objective is to determine whether a recovery of the microstructures of the foveal photoreceptors after macular hole (MH) closure is correlated with the best-corrected visual acuity (BCVA) is determined.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

March 1, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 2, 2011

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

1.4 years

First QC Date

March 1, 2011

Last Update Submit

July 31, 2012

Conditions

Macular Holes

Keywords

macular hole

Outcome Measures

Primary Outcomes (1)

  • Foveal microstructure determined by optical coherence tomography

    The integrity of the microstructures of the foveal photoreceptors; the inner segment/outer segment (IS/OS) junction, the external limiting membrane (ELM), and the cone outer segment tips (COST) line were determined by spectral domain optical coherence tomography.

    Preoperative and postoperative 1, 3, 6, 9, 12 months

Secondary Outcomes (1)

  • The visual acuity

    Preoperative and postoperative 1, 3, 6, 9, 12 months

Study Arms (1)

Macular hole patients

The patients who underwent vitreous surgery for idiopathic macular hole.

Procedure: Vitrectomy

Interventions

VitrectomyPROCEDURE

Macular hole surgery

Also known as: Optical coherence tomography
Macular hole patients

Eligibility Criteria

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

Consecutive patients with surgically-closed MHs after successful vitrectomy

You may qualify if:

  • The patients had undergone surgery from March 2008 to August 2009 at Kyorin Eye Center
  • Idiopathic macular hole patients with either a Stage 2, 3, or 4 according to the Gass classification

You may not qualify if:

  • The presence of other retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy
  • High myopia with an axial length \> 27.0 mm or refractive error \> -8.0 diopters
  • The patients followed for less than 6 months postoperatively

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyorin Eye Center

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

VitrectomyTomography, Optical Coherence

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, OperativeTomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

March 1, 2011

First Posted

March 2, 2011

Study Start

March 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2010

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

JP(1)