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Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

Status
Completed
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01226160
Enrollment
30
Registered
2010-10-22
Start date
2005-01-31
Completion date
2010-10-31
Last updated
2010-10-22

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

Conditions

Full Thickness Macular Hole

Brief summary

This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.

Interventions

PROCEDUREPostoperative face-down posturing

Postoperative face-down posturing for 10 days after surgery.

PROCEDUREPostoperative non-posturing group

avoid a face-up position only for 10 days after surgery

Sponsors

Moorfields Eye Hospital NHS Foundation Trust
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* full thickness macular hole * \>16 years old

Exclusion criteria

* any history of previous intraocular surgery (including cataract surgery) * history of ocular trauma * history of visual loss greater than 1 year

Design outcomes

Primary

MeasureTime frame
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.6 weeks

Secondary

MeasureTime frame
Visual acuity assessed 6 weeks following surgery by Snellen charts.6 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026