Skip to main content
MedPathMedPath Home
Clinical Trials/NCT01020760
NCT01020760
Completed
Not Applicable

Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

NHS Greater Glasgow and Clyde1 site in 1 country30 target enrollmentSeptember 2008
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsFull Thickness Macular Hole

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Full Thickness Macular Hole
Sponsor
NHS Greater Glasgow and Clyde
Enrollment
30
Locations
1
Primary Endpoint
estimate variance and effect size order to inform power calculations for further studies.
Status
Completed
Last Updated
14 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
October 2010
Last Updated
14 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

David Yorston

Consultant Ophthalmologist

NHS Greater Glasgow and Clyde

Eligibility Criteria

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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.

Outcomes

Primary Outcomes

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

Time Frame: one year

Secondary Outcomes

  • visual acuity and complications(one year)
  • estimate recruitment rate and establish protocol/procedure(one year)

Study Sites (1)

Loading locations...

Similar Trials

Unknown
Not Applicable
The Influence of Postoperative Postures on Persistent Sub-foveal Fluid After Scleral Buckle SurgeryRetinal Detachment
NCT02294708Peking University Third Hospital60
Unknown
Not Applicable
The Postoperative Head Position as a Predictor of the Surgical Outcome After DMEKFuchs Endothelial Corneal DystrophyPseudophakic Bullous KeratopathyChemical Burn of CorneaPosterior Polymorphous Corneal Dystrophy
NCT04387331Peter Wiedemann50
Recruiting
Not Applicable
Effects of Prone Position After Major Abdominal SurgerySurgeryComplications, PostoperativeLung Infection
NCT05630443Vastra Gotaland Region200
Completed
Not Applicable
Impact of postoperative positioning on the outcome of pars plana vitrectomy with gas tamponade for primary rhegmatogenous retinal detachment: Comparison between supine and prone positioningrhegmatogenous retinal detachment
JPRN-UMIN000023598Kobe University Hospital50
Completed
Not Applicable
Pilot RCT of posturing following surgery for macular holeEye Diseases: Macular holeEye DiseasesMacular hole
ISRCTN96973836Record Provided by the NHSTCT Register - 2007 Update - Department of Health30