Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
ConditionMacular Holes
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSt. Joseph's Healthcare Hamilton
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Consecutive patients with an idiopathic full-thickness macular hole
Symptom duration of less than 6 months
Patient must agree to participate in this investigation
Disqualifiers
Macular hole minimum diameter >1000 μm
A history of high myopia (> -6)
Traumatic macular hole
Amblyopia
Trial design
Design model
Parallel
Treatments tested in this trial
3 Days of face-down positioning
BehavioralFollowing surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
7 Days of face-down positioning
BehavioralFollowing surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Face-Down Positioning for 3-Days and NightsExperimental treatment 1 intervention
Group B: Face-Down Positioning for 7-Days and NightsActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.2
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.3
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.4
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.Secondary outcomes
1
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-operatively2
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-operatively3
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-operatively4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov