Postoperative Positioning After Surgery for Macular Holes

Glostrup University Hospital, Copenhagen

Status: Completed

Conditions: Macular Holes

Treatments: Procedure: Postoperative face-down positioning; Procedure: Vitrectomy & Intraocular gas fill

Study type: Interventional

Funder types: Other

Identifiers

NCT01974310

MH-FDP-non-FDP

Details and patient eligibility

About

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.

Enrollment: 68 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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68 participants in 2 patient groups

Face-down positioning

Active Comparator group

Description:

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

Treatment:

Procedure: Vitrectomy & Intraocular gas fill

Procedure: Postoperative face-down positioning

Non-face-down positioning

Experimental group

Description:

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

Treatment:

Procedure: Vitrectomy & Intraocular gas fill