Duration of Face Down Positioning for Full-Thickness Macular Hole Repair

Study Overview
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Brief Summary
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A full-thickness macular hole is when there is a small gap that opens in the center part of the retina (the light-sensitive layer of tissue in the back of the eye). Following surgical repair of these holes, patients have to lie face down for a number of days and nights. The exact amount of time necessary to position is however unknown. The goal of this randomized feasibility clinical trial is to compare 3 days and nights of face-down positioning to 7 days and nights of face-down positioning following pars plana vitrectomy surgery for full-thickness macular holes on key patient outcomes. This study will be a feasibility study to better inform a future larger clinical trial. Additionally, this investigation will be examining the rates of macular hole closure, patient visual acuity following surgery, patient quality of life, patient compliance, and complication rates.

Official Title
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Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: A Randomized Feasibility Study

Conditions
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Macular Holes

Intervention / Treatment
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* Behavioral: 3 Days of face-down positioning
* Behavioral: 7 Days of face-down positioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Consecutive patients with an idiopathic full-thickness macular hole Symptom duration of less than 6 months Patient must agree to participate in this investigation Exclusion Criteria: Macular hole minimum diameter >1000 μm A history of high myopia (> -6) Traumatic macular hole Amblyopia Retinal vein occlusion Inflammatory eye diseases Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Face-Down Positioning for 3-Days and Nights<br>Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours. | Behavioral: 3 Days of face-down positioning<br>* Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.<br>|
| Active Comparator: Face-Down Positioning for 7-Days and Nights<br>Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours. | Behavioral: 7 Days of face-down positioning<br>* Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recruitment Rate | This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study. | The recruitment rate will be calculated during the recruitment period. | 
| Retention Rate | This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study. | The retention rate will be calculated at 3-months post-operatively. | 
| Completion Rate | This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study. | The completion rate will be calculated at 3-months post-operatively. | 
| Recruitment Time | This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study. | The recruitment time will be calculated during the recruitment period. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular Hole Closure Rate | The rate of macular hole closure will be evaluated by 2-independent readers masked to treatment allocation. They will grade the outcome as open or closed. Outcomes classified as open will be further divided into open and flat (without a cuff of subretinal fluid) or open and elevated (with a cuff of subretinal fluid). | 3-months post-operatively | 
| Best-Corrected Visual Acuity (BCVA) | Patient best-corrected visual acuity will be measured by Snellen visual acuity. With this measure of visual acuity, visual acuity can range from 20/10 (best) to 20/1000 (worst). If the patient is unable to read the chart at any distance, patients will next be assessed whether they can count figures at a given distance, if not, they will be tested to see whether they can perceive hand motion and if not, if they can perceive any light. | 3-months post-operatively | 
| Vision specific quality of life measure | The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be administered to patients. Possible patient scores range from 0 to 100 with a higher score representing higher vision-related quality of life. | 3-months post-operatively | 
| Compliance with Face Down Positioning | Compliance will be assessed with self-administered questionnaires assessing the patients' compliance during the morning, midday, evening, and overnight. The possible range of scores is from 1 to 10 with higher scores indicating better compliance. | While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation. | 
| Complication Rates | Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage | Rates will be determined for the entire follow-up period (3-months) | 
| Health Related Quality of Life Measure | The Quality of Life Scale (QOLS) will be administered to patients. The range of possible patient scores is from 16 to 112. Higher scores indicate higher quality of life. | 3-months post-operatively |