Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

Full Thickness Macular Hole Clinical Trial

Official title:

Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01020760
• Other study ID #: Version 1
• Status: Completed
• Phase: N/A
• First received: November 25, 2009
• Last updated: April 25, 2012
• Start date: September 2008
• Est. completion date: October 2010

Study information

• Verified date: April 2012
• Source: NHS Greater Glasgow and Clyde
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: October 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

1. Patients having surgery for idiopathic full thickness macular hole

2. Able and willing to posture face-down for 10 days postoperatively

3. Agree to participate in the trial and able to give informed consent

Exclusion Criteria:

1. History of visual loss suggesting a duration of macular hole greater than 12 months

2. Patients unable or unwilling to posture face-down for 10 days postoperatively

3. History of trauma that may have been causative

4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).

5. Previous vitrectomy surgery

6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Full Thickness Macular Hole
• Retinal Perforations

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Gartnavel General Hospital	Glasgow

Sponsors (1)

Lead Sponsor	Collaborator
NHS Greater Glasgow and Clyde

Country where clinical trial is conducted

United Kingdom, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	estimate variance and effect size order to inform power calculations for further studies.		one year	No
Secondary	visual acuity and complications		one year	No
Secondary	estimate recruitment rate and establish protocol/procedure		one year	No