NCT01226160

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
Completed

Started Jan 2005

Longer than P75 for early_phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 22, 2010

Completed
Last Updated

October 22, 2010

Status Verified

August 1, 2006

Enrollment Period

5.1 years

First QC Date

October 21, 2010

Last Update Submit

October 21, 2010

Conditions

Full Thickness Macular Hole

Outcome Measures

Primary Outcomes (1)

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

    6 weeks

Secondary Outcomes (1)

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

    6 weeks

Study Arms (2)

Face-down posturing group

EXPERIMENTAL

Postoperative face-down positioning for 10 days after surgery.

Procedure: Postoperative face-down posturing

Non-posturing group

ACTIVE COMPARATOR

avoid a face-up position for 10 days after surgery

Procedure: Postoperative non-posturing group

Interventions

Postoperative face-down posturingPROCEDURE

Postoperative face-down posturing for 10 days after surgery.

Face-down posturing group
Postoperative non-posturing groupPROCEDURE

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

Non-posturing group

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • full thickness macular hole
  • \>16 years old

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moorfileld's Eye Hospital

London, London, EC1V 2PD, United Kingdom

Location

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 21, 2010

First Posted

October 22, 2010

Study Start

January 1, 2005

Primary Completion

February 1, 2010

Study Completion

October 1, 2010

Last Updated

October 22, 2010

Record last verified: 2006-08

Locations

GB(1)