NCT01020760

Brief Summary

The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

November 25, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 26, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
Last Updated

April 26, 2012

Status Verified

April 1, 2012

Enrollment Period

1.9 years

First QC Date

November 25, 2009

Last Update Submit

April 25, 2012

Conditions

Full Thickness Macular Hole

Keywords

Macular holeVitrectomyProne posturing

Outcome Measures

Primary Outcomes (1)

  • estimate variance and effect size order to inform power calculations for further studies.

    one year

Secondary Outcomes (2)

  • visual acuity and complications

    one year

  • estimate recruitment rate and establish protocol/procedure

    one year

Study Arms (2)

No posture

NO INTERVENTION

Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to avoid supine posturing for seven days after surgery, but will not be advised to posture in the face down or prone position.

Face down posture

EXPERIMENTAL

Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days.

Behavioral: Face down posture

Interventions

Face down postureBEHAVIORAL

Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.

Face down posture

Eligibility Criteria

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

You may qualify if:

  • Patients having surgery for idiopathic full thickness macular hole
  • Able and willing to posture face-down for 10 days postoperatively
  • Agree to participate in the trial and able to give informed consent

You may not qualify if:

  • History of visual loss suggesting a duration of macular hole greater than 12 months
  • Patients unable or unwilling to posture face-down for 10 days postoperatively
  • History of trauma that may have been causative
  • Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
  • Previous vitrectomy surgery
  • Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gartnavel General Hospital

Glasgow, G12 0YN, United Kingdom

Location

Related Publications (1)

  • Yorston D, Siddiqui MA, Awan MA, Walker S, Bunce C, Bainbridge JW. Pilot randomised controlled trial of face-down posturing following phacovitrectomy for macular hole. Eye (Lond). 2012 Feb;26(2):267-71. doi: 10.1038/eye.2011.220. Epub 2011 Sep 23. Erratum In: Eye (Lond). 2012 Feb;26(2):341.

    PMID: 21941363RESULT

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal DiseasesEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Ophthalmologist

Study Record Dates

First Submitted

November 25, 2009

First Posted

November 26, 2009

Study Start

September 1, 2008

Primary Completion

August 1, 2010

Study Completion

October 1, 2010

Last Updated

April 26, 2012

Record last verified: 2012-04

Locations

GB(1)