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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Yorston, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier:
NCT01020760
First received: November 25, 2009
Last updated: April 25, 2012
Last verified: April 2012
  Purpose

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 Intervention
Full Thickness Macular Hole
Behavioral: Face down posture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

Further study details as provided by NHS Greater Glasgow and Clyde:

Primary Outcome Measures:
  • estimate variance and effect size order to inform power calculations for further studies. [ Time Frame: one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • visual acuity and complications [ Time Frame: one year ] [ Designated as safety issue: No ]
  • estimate recruitment rate and establish protocol/procedure [ Time Frame: one year ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2008
Study Completion Date: October 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020760

Locations
United Kingdom
Gartnavel General Hospital
Glasgow, United Kingdom, G12 0YN
Sponsors and Collaborators
NHS Greater Glasgow and Clyde
  More Information

Publications:
Responsible Party: David Yorston, Consultant Ophthalmologist, NHS Greater Glasgow and Clyde
ClinicalTrials.gov Identifier: NCT01020760     History of Changes
Other Study ID Numbers: Version 1
Study First Received: November 25, 2009
Last Updated: April 25, 2012
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by NHS Greater Glasgow and Clyde:
Macular hole
Vitrectomy
Prone posturing

Additional relevant MeSH terms:
Retinal Perforations
Eye Diseases
Retinal Diseases

ClinicalTrials.gov processed this record on November 20, 2014