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

Moorfields Eye Hospital NHS Foundation Trust

Status and phase: Completed; Early Phase 1

Conditions: Full Thickness Macular Hole

Treatments: Procedure: Postoperative face-down posturing; Procedure: Postoperative non-posturing group

Study type: Interventional

Funder types: Other

Identifiers

NCT01226160

06/Q0603/100/01

Details and patient eligibility

About

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

Enrollment: 30 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Face-down posturing group

Experimental group

Description:

Postoperative face-down positioning for 10 days after surgery.

Treatment:

Procedure: Postoperative face-down posturing

Non-posturing group

Active Comparator group

Description:

avoid a face-up position for 10 days after surgery

Treatment:

Procedure: Postoperative non-posturing group