Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Face-Down Positioning for 3-Days and Nights 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
Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.
|
| Active Comparator: Face-Down Positioning for 7-Days and Nights 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 7-days and nights of face-down positioning post-operatively.
|
Outcome Measures
Primary Outcome Measures
- Recruitment Rate [The recruitment rate will be calculated during the recruitment period.]
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.
- Retention Rate [The retention rate will be calculated at 3-months post-operatively.]
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.
- Completion Rate [The completion rate will be calculated at 3-months post-operatively.]
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.
- Recruitment Time [The recruitment time will be calculated during the recruitment period.]
This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.
Secondary Outcome Measures
- Macular Hole Closure Rate [3-months post-operatively]
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).
- Best-Corrected Visual Acuity (BCVA) [3-months post-operatively]
Patient best-corrected visual acuity will be measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter score.
- Vision specific quality of life measure [3-months post-operatively]
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.
- Compliance with Face Down Positioning [While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.]
Compliance will be assessed with self-administered questionnaires three times per day during the duration of positioning. The possible range of scores is from 1 to 10 with higher scores indicating better compliance.
- Complication Rates [Rates will be determined for the entire follow-up period (3-months)]
Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage
- Health Related Quality of Life Measure [3-months post-operatively]
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.
Eligibility Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- St. Joseph's Healthcare Hamilton
Investigators
- Principal Investigator: Varun Chaudhary, MD, FRCSC, McMaster University, St. Joseph's Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 16100