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

Qualifiers

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

Treatments tested in this trial

  • 3 Days of face-down positioning
  • 7 Days of face-down positioning

Treatment groups

40 Participants
are divided into 2 treatment groups