NCT01381965

Brief Summary

Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the repair of photoreceptor cone outer segment tips defect is significantly correlated with the visual outcomes after macular hole surgery.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2008

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 21, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 27, 2011

Completed
Last Updated

August 2, 2012

Status Verified

July 1, 2012

Enrollment Period

1.9 years

First QC Date

June 21, 2011

Last Update Submit

July 31, 2012

Conditions

Macular Holes

Keywords

spectral-domain optical coherence tomographyidiopathic macular holecone outer segment tips linevitrectomy

Outcome Measures

Primary Outcomes (1)

  • Visual acuity

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

    one year

Secondary Outcomes (1)

  • Integrity of cone outer segment tips line

    one year

Study Arms (1)

Eyes with macular hole

ACTIVE COMPARATOR
Procedure: Vitreous surgery for macular hole

Interventions

Vitreous surgery for macular holePROCEDURE

Vitreous surgery for macular hole

Eyes with macular hole

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • macular hole patients with surgically-closed hole

You may not qualify if:

  • macular hole patients failed to close hole
  • presence of retinal diseases including a treated rhegmatogenous retinal detachment, diabetic retinopathy, and high myopia with an axial length \>27.0mm or refractive error \> -8.0 diopters(D).
  • patients who were not followed at least 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Makoto Inoue

Mitaka, Tokyo, 181-8611, Japan

Location

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Officials

  • Makoto Inoue, MD

    Kyorin Eye Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

June 21, 2011

First Posted

June 27, 2011

Study Start

March 1, 2008

Primary Completion

February 1, 2010

Study Completion

February 1, 2011

Last Updated

August 2, 2012

Record last verified: 2012-07

Locations

JP(1)