CClinicalTrials.gg
CompletedNCT01226160Updated Oct 22, 2010

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

An Early Phase 1 interventional study of Postoperative face-down posturing and Postoperative non-posturing group in Full Thickness Macular Hole, sponsored by Moorfields Eye Hospital NHS Foundation Trust. Completed at 1 site in United Kingdom. Open to participants aged 16 Years and older. Per ClinicalTrials.gov, last updated 2010-10-22.

Sponsored by Moorfields Eye Hospital NHS Foundation Trust · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
16 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Full Thickness Macular Hole

Browse trials for

03

In context

Retinal Perforations

156 studies on the registry are indexed under Retinal Perforations; 21 are open to participants now.

This study's enrollment of 30 is below the median of 44 across 104 interventional studies indexed under Retinal Perforations.

Browse Retinal Perforations studies →

Lead sponsor

Moorfields Eye Hospital NHS Foundation Trust is the lead sponsor of 48 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • full thickness macular hole
  • >16 years old

Exclusion criteria

Exclusion Criteria:

  • any history of previous intraocular surgery (including cataract surgery)
  • history of ocular trauma
  • history of visual loss greater than 1 year
05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Face-down posturing group

    Postoperative face-down positioning for 10 days after surgery.

    Procedure: Postoperative face-down posturing

  • Active comparator
    Non-posturing group

    avoid a face-up position for 10 days after surgery

    Procedure: Postoperative non-posturing group

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

06

What researchers measure

Primary outcomes

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

    Time frame: 6 weeks

Secondary outcomes

  1. Visual acuity assessed 6 weeks following surgery by Snellen charts.

    Time frame: 6 weeks

07

Study locations

1 site
  • Moorfileld's Eye Hospital
    London, EC1V 2PD, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01226160
Lead sponsor
Moorfields Eye Hospital NHS Foundation Trust
First posted
Oct 22, 2010
Start date
Jan 2005
Primary completion
Feb 2010
Completion
Oct 2010
Last update
Oct 22, 2010

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2006. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion