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

April 25, 2012 updated by: David Yorston, NHS Greater Glasgow and Clyde

Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Glasgow, United Kingdom, G12 0YN
        • Gartnavel General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
estimate variance and effect size order to inform power calculations for further studies.
Time Frame: one year
one year

Secondary Outcome Measures

Outcome Measure
Time Frame
visual acuity and complications
Time Frame: one year
one year
estimate recruitment rate and establish protocol/procedure
Time Frame: one year
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NHS Greater Glasgow and Clyde

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2008

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

October 1, 2010

Study Registration Dates

First Submitted

November 25, 2009

First Submitted That Met QC Criteria

November 25, 2009

First Posted (ESTIMATE)

November 26, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 26, 2012

Last Update Submitted That Met QC Criteria

April 25, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Version 1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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