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Postoperative Positioning After Surgery for Macular Holes

Sponsor
Glostrup University Hospital, Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT01974310
Collaborator
(none)
68
Enrollment
1
Location
2
Arms
17
Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Vitrectomy & Intraocular gas fill
  • Procedure: Postoperative face-down positioning
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
68 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Randomized Clinical Trial of Face-down Protocol Versus Non-face-down Protocol After Surgery for Macular Holes.
Study Start Date :
Oct 1, 2013
Actual Primary Completion Date :
Dec 1, 2014
Actual Study Completion Date :
Mar 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Macular hole closure rate [3 months]

    Macular hole closure rate assessed by optical coherence tomography

Secondary Outcome Measures

  1. ETDRS Visual Acuity Gain [3 months]

  2. Degree of postoperative head incline [3 days]

    Position Sensor

  3. Degree of ocular gas fill [4 days]

Other Outcome Measures

  1. Frequency of the complications [During 3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Glostrup Hospital, University of Copenhagen Copenhagen Denmark 2600

Sponsors and Collaborators

  • Glostrup University Hospital, Copenhagen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mark Alberti, M.D., Glostrup University Hospital, Copenhagen
ClinicalTrials.gov Identifier:
NCT01974310
Other Study ID Numbers:
  • MH-FDP-non-FDP
First Posted:
Nov 1, 2013
Last Update Posted:
Feb 11, 2016
Last Verified:
Feb 1, 2016
Keywords provided by Mark Alberti, M.D., Glostrup University Hospital, Copenhagen
Macular Holes
Non face down positioning
Face down positioning
Additional relevant MeSH terms:
Retinal Perforations

Study Results

No Results Posted as of Feb 11, 2016