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

Full Thickness Macular Hole Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226160
• Other study ID #: 06/Q0603/100/01
• Status: Completed
• Phase: Phase 0
• First received: October 21, 2010
• Last updated: October 21, 2010
• Start date: January 2005
• Est. completion date: October 2010

Study information

• Verified date: August 2006
• Source: Moorfields Eye Hospital NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

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

Eligibility

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

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

Procedure:
• Postoperative face-down posturing
Postoperative face-down posturing for 10 days after surgery.
• Postoperative non-posturing group
avoid a face-up position only for 10 days after surgery

Locations

Country	Name	City	State
United Kingdom	Moorfileld's Eye Hospital	London

Sponsors (1)

Lead Sponsor	Collaborator
Moorfields Eye Hospital NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical closure of the macula hole assessed 6 weeks following surgery by ocular coherence tomography.		6 weeks	Yes
Secondary	Visual acuity assessed 6 weeks following surgery by Snellen charts.		6 weeks	Yes