Duration of Face Down Positioning for Full-Thickness Macular Hole Repair

St. Joseph's Healthcare Hamilton

Status: Enrolling

Conditions: Macular Holes

Treatments: Behavioral: 3 Days of face-down positioning; Behavioral: 7 Days of face-down positioning

Study type: Interventional

Funder types: Other

Identifiers

NCT06000111

16100

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Face-Down Positioning for 3-Days and Nights

Experimental group

Description:

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.

Treatment:

Behavioral: 3 Days of face-down positioning

Face-Down Positioning for 7-Days and Nights

Active Comparator group

Description:

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.

Treatment:

Behavioral: 7 Days of face-down positioning