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

Sponsor

NHS Greater Glasgow and Clyde (Other)

Overall Status

Completed

CT.gov ID

NCT01020760

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Full Thickness Macular Hole	Behavioral: Face down posture	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

Study Start Date :

Sep 1, 2008

Actual Primary Completion Date :

Aug 1, 2010

Actual Study Completion Date :

Oct 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No posture 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.
Experimental: Face down posture 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 Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.

Arm

Intervention/Treatment

No Intervention: No posture

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.

Experimental: Face down posture

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

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

Outcome Measures

Primary Outcome Measures

estimate variance and effect size order to inform power calculations for further studies. [one year]

Secondary Outcome Measures

visual acuity and complications [one year]
estimate recruitment rate and establish protocol/procedure [one year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gartnavel General Hospital	Glasgow		United Kingdom	G12 0YN

Sponsors and Collaborators

NHS Greater Glasgow and Clyde

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

David Yorston, Consultant Ophthalmologist, NHS Greater Glasgow and Clyde

ClinicalTrials.gov Identifier:

NCT01020760

Other Study ID Numbers:

Version 1

First Posted:

Nov 26, 2009

Last Update Posted:

Apr 26, 2012

Last Verified:

Apr 1, 2012

Keywords provided by David Yorston, Consultant Ophthalmologist, NHS Greater Glasgow and Clyde

Macular hole

Vitrectomy

Prone posturing

Additional relevant MeSH terms:

Retinal Perforations

Study Results

No Results Posted as of Apr 26, 2012