Clinical trial NCT06000111: Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Official title: Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Macular Holes
Lead sponsor: St. Joseph's Healthcare Hamilton
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment Rate
timeFrame: The recruitment rate will be calculated during the recruitment period.
measure: Retention Rate
timeFrame: The retention rate will be calculated at 3-months post-operatively.
measure: Completion Rate
timeFrame: The completion rate will be calculated at 3-months post-operatively.
measure: Recruitment Time
timeFrame: The recruitment time will be calculated during the recruitment period.
Secondary outcomes:
measure: Macular Hole Closure Rate
timeFrame: 3-months post-operatively
measure: Best-Corrected Visual Acuity (BCVA)
timeFrame: 3-months post-operatively
measure: Vision specific quality of life measure
timeFrame: 3-months post-operatively
measure: Compliance with Face Down Positioning
timeFrame: While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.
measure: Complication Rates
timeFrame: Rates will be determined for the entire follow-up period (3-months)
measure: Health Related Quality of Life Measure
timeFrame: 3-months post-operatively
Other outcomes:
Locations:
city: Stoney Creek
country: Canada
facility: St. Joseph's Hospital King Campus
state: Ontario
Study officials:
affiliation: McMaster University, St. Joseph's Hospital
name: Varun Chaudhary, MD, FRCSC
role: PRINCIPAL_INVESTIGATOR
References: