Comparing 3 Days of face-down positioning with 7 Days of face-down positioning for macular holes
Official title: Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
- 2 groups
- One site, in Stoney Creek
- Recruiting
Interventions
- Behavioural therapy
3 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.
- Behavioural therapy
7 Days of face-down positioning
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
Canadian Sites (1)
1 of 1 recruiting
- Recruiting
St. Joseph's Hospital King Campus
Stoney Creek, Ontario
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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
- −Macular hole minimum diameter \>1000 μm
- −A history of high myopia (\> -6)
- −Traumatic macular hole
- −Retinal vein occlusion
- −Inflammatory eye diseases
- −Patients found to have a retinal tear during either the pre-operative assessment or intraoperatively
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives 3 Days of face-down positioning.
Registry label: A: Face-Down Positioning for 3-Days and Nights
Group B, the comparison group, receives 7 Days of face-down positioning.
Registry label: B: Face-Down Positioning for 7-Days and Nights
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
One group of people involved — usually the participants — is not told which treatment is which.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 40 people.
The study is currently expected to finish around December 2025.
The main measurement is taken over: The recruitment rate will be calculated during the recruitment period.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Recruitment Rate — measured over The recruitment rate will be calculated during the recruitment period.
Retention Rate — measured over The retention rate will be calculated at 3-months post-operatively.
Completion Rate — measured over The completion rate will be calculated at 3-months post-operatively.
Recruitment Time — measured over The recruitment time will be calculated during the recruitment period.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06000111 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About 3 Days of face-down positioningBehavioural
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
About 7 Days of face-down positioningBehavioural
Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
From the trial registry — its own words, unedited.
What a behavioural is here: A programme, therapy, education, or lifestyle approach being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
One group of people involved — usually the participants — is not told which treatment is which.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: The recruitment rate will be calculated during the recruitment period..
The study as a whole is currently expected to finish around 2025-12-31.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 40 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists one location: Stoney Creek, Ontario, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.