NCT02650739

Brief Summary

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images was compared with the surgery by the surgeon's decision. The macular hole closure and visual outcome were compared.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
125

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2013

Typical duration for all trials

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

May 1, 2013

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 6, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 8, 2016

Completed
Last Updated

January 8, 2016

Status Verified

January 1, 2016

Enrollment Period

2.3 years

First QC Date

January 6, 2016

Last Update Submit

January 6, 2016

Conditions

Macular Hole Surgery

Outcome Measures

Primary Outcomes (1)

  • Macular hole closure

    Closure of macular hole

    Changes from baseline to 1, 2 months

Secondary Outcomes (1)

  • Visual acuity before and after surgery

    Changes from baseline to 1, 2 months

Study Arms (2)

SS-OCTdetermined group

Eyes with macular hole surgery that the postoperative prone positioning was discontinued after detecting a closure by SS-OCT

Procedure: Macular hole surgery

Control group

Eyes with macular hole surgery that the halting of the prone position was determined by the surgeon

Procedure: Macular hole surgery

Interventions

Macular hole surgeryPROCEDURE

Vitrectomy with internal limiting membrane removal and gas tamponade

Also known as: Vitrectomy
Control groupSS-OCTdetermined group

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The efficacy of macular hole (MH) surgery with the halting of prone positioning by monitoring the MH closure in the swept source optical coherence tomographic (SS-OCT) images in 60 eyes was compared with the 69 eyes with same surgical procedure but the prone position determined by the surgeon's decision.

You may qualify if:

  • The patients were followed more than 2 months.

You may not qualify if:

  • Eye with axial length more than 26.0 mm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Ophthalmology

Study Record Dates

First Submitted

January 6, 2016

First Posted

January 8, 2016

Study Start

May 1, 2013

Primary Completion

August 1, 2015

Study Completion

October 1, 2015

Last Updated

January 8, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share