An interventional study of 3 Days of face-down positioning and 7 Days of face-down positioning in Macular Holes, sponsored by St. Joseph's Healthcare Hamilton. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-11-29.
Sponsored by St. Joseph's Healthcare Hamilton · Not applicable, Interventional, and Treatment
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.
139 studies on the registry are indexed under Retinal Perforations; 22 are open to participants now.
This study's planned enrollment of 40 is below the median of 50 across 94 interventional studies indexed under Retinal Perforations.
Browse Retinal Perforations studies →St. Joseph's Healthcare Hamilton is the lead sponsor of 143 studies on the registry; 33 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: The recruitment time will be calculated during the recruitment period.
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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 3-months post-operatively
Plan to share: No — Individual participant data may be shared with other researchers upon reasonable request.
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
St. Joseph's Healthcare Hamilton →