NCT01974310

Brief Summary

Idiopathic macular holes are an important cause of visual loss. Macular holes can be treated by surgically removing the vitreous gel and injecting intraocular gas. Following macular hole surgery, face-down positioning is often advised with the aim of improving the likelihood of macular hole closure. The current evidence of postoperative positioning protocols is insufficient to draw firm conclusions and guide practice. The investigators wish to compare non-face-down positioning and face-down positioning after surgery for macular holes in a randomized trial. Hypothesis: Non-face-down positioning is equivalent to face-down positioning after surgery for macular holes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

October 26, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 1, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 11, 2016

Status Verified

February 1, 2016

Enrollment Period

1.2 years

First QC Date

October 26, 2013

Last Update Submit

February 10, 2016

Conditions

Macular Holes

Keywords

Macular HolesNon face down positioningFace down positioning

Outcome Measures

Primary Outcomes (1)

  • Macular hole closure rate

    Macular hole closure rate assessed by optical coherence tomography

    3 months

Secondary Outcomes (3)

  • ETDRS Visual Acuity Gain

    3 months

  • Degree of postoperative head incline

    3 days

  • Degree of ocular gas fill

    4 days

Other Outcomes (1)

  • Frequency of the complications

    During 3 months

Study Arms (2)

Face-down positioning

ACTIVE COMPARATOR

Patients advised face-down positioning after surgery for macular hole.

Procedure: Vitrectomy & Intraocular gas fillProcedure: Postoperative face-down positioning

Non-face-down positioning

EXPERIMENTAL

Patients advised non-face-down positioning after surgery for macular hole.

Procedure: Vitrectomy & Intraocular gas fill

Interventions

Vitrectomy & Intraocular gas fillPROCEDURE
Face-down positioningNon-face-down positioning
Postoperative face-down positioningPROCEDURE
Face-down positioning

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Idiopathic macular hole stage II-IV
  • Informed consent
  • Duration of symptoms ≤ 24 months

You may not qualify if:

  • Previous vitreomacular surgery
  • Myopia ≥ 8 diopters
  • Ocular trauma
  • Disease affecting visual function (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup Hospital, University of Copenhagen

Copenhagen, 2600, Denmark

Location

MeSH Terms

Conditions

Retinal Perforations

Interventions

Vitrectomy

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Ophthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Morten la Cour, Professor

    Glostrup University Hospital, Copenhagen

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D.

Study Record Dates

First Submitted

October 26, 2013

First Posted

November 1, 2013

Study Start

October 1, 2013

Primary Completion

December 1, 2014

Study Completion

March 1, 2015

Last Updated

February 11, 2016

Record last verified: 2016-02

Locations

DK(1)