Postoperative Positioning After Surgery for Macular Holes

Not Applicable

Completed

• Conditions: Macular Holes
• Interventions: Procedure: Vitrectomy & Intraocular gas fill; Procedure: Postoperative face-down positioning

• Registration Number: NCT01974310
• Lead Sponsor: Glostrup University Hospital, Copenhagen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-26
• Study First Submitted QC: 2013-10-31
• Study First Posted: 2013-11-01
• Primary Completion: 2014-12
• Study Completion: 2015-03
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-10
• Last Update Posted: 2016-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Face-down positioning	Postoperative face-down positioning	Patients advised face-down positioning after surgery for macular hole.
Face-down positioning	Vitrectomy & Intraocular gas fill	Patients advised face-down positioning after surgery for macular hole.
Non-face-down positioning	Vitrectomy & Intraocular gas fill	Patients advised non-face-down positioning after surgery for macular hole.

Primary Outcome Measures

Name	Time	Method
Macular hole closure rate	3 months	Macular hole closure rate assessed by optical coherence tomography

Secondary Outcome Measures

Name	Time	Method
ETDRS Visual Acuity Gain	3 months
Degree of postoperative head incline	3 days	Position Sensor
Degree of ocular gas fill	4 days

Trial Locations

Locations (1)

Glostrup Hospital, University of Copenhagen; 🇩🇰 Copenhagen, Denmark