Pilot Randomised Controlled Trial of Posturing Following Surgery for Full-thickness Macular Hole

Early Phase 1

Completed

• Conditions: Full Thickness Macular Hole
• Interventions: Procedure: Postoperative non-posturing group; Procedure: Postoperative face-down posturing

• Registration Number: NCT01226160
• Lead Sponsor: Moorfields Eye Hospital NHS Foundation Trust

Brief Summary

This is a pilot randomised controlled trial (RCT) to investigate the effect of postoperative face-down positioning on the outcome of macular hole surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Status Verified: 2006-08
• Primary Completion: 2010-02
• Study Completion: 2010-10
• Study First Submitted: 2010-10-21
• Study First Submitted QC: 2010-10-21
• Last Update Submitted: 2010-10-21
• Study First Posted: 2010-10-22
• Last Update Posted: 2010-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• full thickness macular hole
• >16 years old

Exclusion Criteria

• any history of previous intraocular surgery (including cataract surgery)
• history of ocular trauma
• history of visual loss greater than 1 year

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-posturing group	Postoperative non-posturing group	avoid a face-up position for 10 days after surgery
Face-down posturing group	Postoperative face-down posturing	Postoperative face-down positioning for 10 days after surgery.

Primary Outcome Measures

Name	Time	Method
Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.	6 weeks

Secondary Outcome Measures

Name	Time	Method
Visual acuity assessed 6 weeks following surgery by Snellen charts.	6 weeks

Trial Locations

Locations (1)

Moorfileld's Eye Hospital; 🇬🇧 London, United Kingdom