Back to resultsProtocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
Primary Purpose
Full Thickness Macular Hole
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Face down posture
Sponsored by
About this trial
This is an interventional treatment trial for Full Thickness Macular Hole focused on measuring Macular hole, Vitrectomy, Prone posturing
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.
Sites / Locations
- Gartnavel General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
No posture
Face down posture
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
estimate variance and effect size order to inform power calculations for further studies.
Secondary Outcome Measures
visual acuity and complications
estimate recruitment rate and establish protocol/procedure
Full Information
NCT ID
NCT01020760
First Posted
November 25, 2009
Last Updated
April 25, 2012
Sponsor
NHS Greater Glasgow and Clyde
1. Study Identification
Unique Protocol Identification Number
NCT01020760
Brief Title
Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
Official Title
Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
NHS Greater Glasgow and Clyde
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Full Thickness Macular Hole
Keywords
Macular hole, Vitrectomy, Prone posturing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
No posture
Arm Type
No Intervention
Arm Description
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.
Arm Title
Face down posture
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Face down posture
Intervention Description
Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.
Primary Outcome Measure Information:
Title
estimate variance and effect size order to inform power calculations for further studies.
Time Frame
one year
Secondary Outcome Measure Information:
Title
visual acuity and complications
Time Frame
one year
Title
estimate recruitment rate and establish protocol/procedure
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Gartnavel General Hospital
City
Glasgow
ZIP/Postal Code
G12 0YN
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
21941363
Citation
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.
Results Reference
result
Learn more about this trial
Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)
We'll reach out to this number within 24 hrs