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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Face-Down Positioning for 3-Days and Nights | Experimental | 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. |
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| Face-Down Positioning for 7-Days and Nights | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 3 Days of face-down positioning | Behavioral | Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively. |
| 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. |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Varun Chaudhary, MD, FRCSC | Contact | 905-573-7777 | 38058 | vchaudh@mcmaster.ca |
| Keean Nanji, MD | Contact | 905-573-4848 | Keean.Nanji@medportal.ca |
| Name | Affiliation | Role |
|---|---|---|
| Varun Chaudhary, MD, FRCSC | McMaster University, St. Joseph's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Joseph's Hospital King Campus | Recruiting | Stoney Creek | Ontario | L8G 5E4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39163327 | Derived | Nanji K, Oquendo PL, Srinivasan S, Vyas C, Prasad F, Farrokhyar F, Chaudhary V. Duration of face down positioning following full-thickness macular hole repair: A protocol for a randomized pilot study. PLoS One. 2024 Aug 20;19(8):e0304566. doi: 10.1371/journal.pone.0304566. eCollection 2024. |
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Individual participant data may be shared with other researchers upon reasonable request.
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| ID | Term |
|---|---|
| D012167 | Retinal Perforations |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
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This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.
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The surgeon will be masked to the patient's treatment allocation until after surgery is complete. At this point, the surgeon will be made aware of the patient's treatment allocation and inform the patient in the recovery room regarding their treatment allocation. The participants and the clinical teams managing the patient care will be unmasked. The outcome assessors will be masked.
| 7 Days of face-down positioning | Behavioral | Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively. |
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| 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 |