Postoperative Positioning After Surgery for Macular Holes

February 10, 2016 updated by: Mark Alberti, Glostrup University Hospital, Copenhagen

A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2600
        • Glostrup Hospital, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Face-down positioning
Patients advised face-down positioning after surgery for macular hole.
Procedure: Vitrectomy & Intraocular gas fill
Procedure: Postoperative face-down positioning
EXPERIMENTAL: Non-face-down positioning
Patients advised non-face-down positioning after surgery for macular hole.
Procedure: Vitrectomy & Intraocular gas fill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Macular hole closure rate
Time Frame: 3 months
Macular hole closure rate assessed by optical coherence tomography
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ETDRS Visual Acuity Gain
Time Frame: 3 months
3 months
Degree of postoperative head incline
Time Frame: 3 days
Position Sensor
3 days
Degree of ocular gas fill
Time Frame: 4 days
4 days

Other Outcome Measures

Outcome Measure
Time Frame
Frequency of the complications
Time Frame: During 3 months
During 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Glostrup University Hospital, Copenhagen

Investigators

  • Study Director: Morten la Cour, Professor, Glostrup University Hospital, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2013

Primary Completion (ACTUAL)

December 1, 2014

Study Completion (ACTUAL)

March 1, 2015

Study Registration Dates

First Submitted

October 26, 2013

First Submitted That Met QC Criteria

October 31, 2013

First Posted (ESTIMATE)

November 1, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2016

Last Update Submitted That Met QC Criteria

February 10, 2016

Last Verified

February 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MH-FDP-non-FDP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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