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Pilot RCT of posturing following surgery for macular hole

Completed
Conditions
Eye Diseases: Macular hole
Eye Diseases
Macular hole
Registration Number
ISRCTN96973836
Lead Sponsor
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

1. Patients listed for 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 give informed consent

Exclusion Criteria

1. History of visual loss suggesting a duration of macular hole > 12 months
2. Patients unwilling or unable to posture face down for 10 days postoperatively
3. History of trauma which may have been causative
4. Age less than 18 years old in UK or less than 16 years old in Scotland
5. Previous vitrectomy surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
1. Variance and effect size to inform power calculation for a full study<br>2. Recruitment rate<br>3. Establish procedures and protocols
Secondary Outcome Measures
NameTimeMethod
1. Macular hole closure<br>2. Visual acuity<br>3. Complications<br>4. Differences in answer to patient survey questions between the 2 groups
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