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

Early Phase 1CompletedNCT01226160

Moorfields Eye Hospital NHS Foundation Trust30 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Full Thickness Macular Hole

Interventions

Postoperative face-down posturingPROCEDURE

Postoperative face-down posturing for 10 days after surgery.

Postoperative non-posturing groupPROCEDURE

avoid a face-up position only for 10 days after surgery

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Moorfileld's Eye Hospital

London, London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: 6 weeks

Secondary Outcomes

Visual acuity assessed 6 weeks following surgery by Snellen charts.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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