Postoperative Positioning After Surgery for Macular Holes

NCT ID: NCT01974310

Last Updated: 2016-02-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2015-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Face-down positioning

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

Group Type ACTIVE_COMPARATOR

Vitrectomy & Intraocular gas fill

Intervention Type PROCEDURE

Postoperative face-down positioning

Intervention Type PROCEDURE

Non-face-down positioning

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

Group Type EXPERIMENTAL

Vitrectomy & Intraocular gas fill

Intervention Type PROCEDURE

Interventions

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Vitrectomy & Intraocular gas fill

Intervention Type PROCEDURE

Postoperative face-down positioning

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

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

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Glostrup University Hospital, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Mark Alberti

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Morten la Cour, Professor

Role: STUDY_DIRECTOR

Glostrup University Hospital, Copenhagen

Locations

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Glostrup Hospital, University of Copenhagen

Copenhagen, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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MH-FDP-non-FDP

Identifier Type: -

Identifier Source: org_study_id

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