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

NCT ID: NCT01226160

Last Updated: 2010-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2010-10-31

Brief Summary

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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

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Conditions

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Full Thickness Macular Hole

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Face-down posturing group

Postoperative face-down positioning for 10 days after surgery.

Group Type EXPERIMENTAL

Postoperative face-down posturing

Intervention Type PROCEDURE

Postoperative face-down posturing for 10 days after surgery.

Non-posturing group

avoid a face-up position for 10 days after surgery

Group Type ACTIVE_COMPARATOR

Postoperative non-posturing group

Intervention Type PROCEDURE

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

Interventions

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Postoperative face-down posturing

Postoperative face-down posturing for 10 days after surgery.

Intervention Type PROCEDURE

Postoperative non-posturing group

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Moorfields Eye Hospital NHS Foundation Trust

OTHER

Sponsor Role lead

Locations

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Moorfileld's Eye Hospital

London, London, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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06/Q0603/100/01

Identifier Type: -

Identifier Source: org_study_id