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Positioning in macular hole surgery

A multicentre interventional comparative randomised controlled clinical trial comparing face-down positioning with an inactive face-forward position on the outcome of surgery for large macular holes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN12410596
Enrollment
192
Registered
2015-02-11
Start date
2015-05-01
Completion date
Unknown
Last updated
2020-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Topic: Ophthalmology

Interventions

Positioning in macular surgery. The intervention is advice to position face-down following surgery for a total of at least 8 consecutive or non-consecutive hours daily for 5 days. The comparison is ad

Sponsors

Moorfields Eye Hospital NHS Foundation Trust
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Presence of idiopathic full-thickness macular hole, greater than or equal to 400 µm in diameter as measured OCT 2. Patients electing to have surgery for macular hole, with or without simultaneous phacoemulsification and intra-ocular lens implant 3. Ability and willingness to position face-down or in an inactive faceforward position 4. Lower age limit 18 years

Exclusion criteria

Exclusion criteria: 1. Age-related macular degeneration; glaucoma; diabetic retinopathy; retinal degeneration; amblyopia; previous vitrectomy surgery (refractive error, lens opacity and previous use of ocriplasmin are not exclusion criteria) 2. Traumatic macular hole 3. History of visual loss suggesting macular hole duration longer than 12 months 4. Presence of a retinal tear identified during surgery for which post operative positioning is advised

Design outcomes

Primary

MeasureTime frame
Anatomical closure of the macular hole; Timepoint(s): Determined at three months after surgery by masked assessment of OCT scans.

Secondary

MeasureTime frame
To determine the impact of face-down positioning on sight, quality of life and wellbeing.

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 9, 2026