Protocol for RCT of Posturing in Phacovitrectomy for Full Thickness Macular Hole (FTMH)

NHS Trust

Status: Completed

Conditions: Full Thickness Macular Hole

Treatments: Behavioral: Face down posture

Study type: Interventional

Funder types: Other

Identifiers

NCT01020760

Version 1

Details and patient eligibility

About

The purpose of this study is to determine the effect of postoperative posturing on the outcome of macular hole surgery. Current practice is divided; some individuals are advised to posture face-down for 10 days and others are advised that posturing is unnecessary. By evaluating the effect of posturing in a prospective randomised controlled trial the investigators hope to determine best practice, enabling surgeons and patients to make informed decisions regarding postoperative management.

Enrollment: 30 patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients having 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 able to give informed consent

Exclusion criteria

1. History of visual loss suggesting a duration of macular hole greater than 12 months
2. Patients unable or unwilling to posture face-down for 10 days postoperatively
3. History of trauma that may have been causative
4. Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years).
5. Previous vitrectomy surgery
6. Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

No posture

No Intervention group

Description:

Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to avoid supine posturing for seven days after surgery, but will not be advised to posture in the face down or prone position.

Face down posture

Experimental group

Description:

Patients will undergo routine phacoemulsification, pars plana vitrectomy, ILM peel and gas fluid exchange with 14% C3F8. They will be advised to posture in the face down or prone position for 50 minutes per hour for seven days.

Treatment:

Behavioral: Face down posture