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

Study Overview
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Brief Summary
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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.

Official Title
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Pilot Study of Prone Posturing Following Phacovitrectomy for Thickness Macular Hole

Conditions
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Full Thickness Macular Hole

Intervention / Treatment
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* Behavioral: Face down posture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having surgery for idiopathic full thickness macular hole Able and willing to posture face-down for 10 days postoperatively Agree to participate in the trial and able to give informed consent Exclusion Criteria: History of visual loss suggesting a duration of macular hole greater than 12 months Patients unable or unwilling to posture face-down for 10 days postoperatively History of trauma that may have been causative Age less than 16 years (in practice idiopathic macular hole is extremely rare in patients under 30 years). Previous vitrectomy surgery Additional retinal breaks occurring during surgery that necessitate post-operative posturing to prevent retinal detachment.

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No posture<br>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. | |
| Experimental: Face down posture<br>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. | Behavioral: Face down posture<br>* Patients are requested to maintain a strict face down posture for 50 minutes out of every hour for seven days after surgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| estimate variance and effect size order to inform power calculations for further studies. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity and complications |  | one year | 
| estimate recruitment rate and establish protocol/procedure |  | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Macular hole, Vitrectomy, Prone posturing