RecruitingNot ApplicableNCT06000111

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

Duration of Face Down Positioning Following Full-Thickness Macular Hole Repair: a Randomized Feasibility Study


Sponsor

St. Joseph's Healthcare Hamilton

Enrollment

40 participants

Start Date

Nov 21, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria7

  • 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

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Interventions

BEHAVIORAL3 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.

BEHAVIORAL7 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.


Locations(1)

St. Joseph's Hospital King Campus

Stoney Creek, Ontario, Canada

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NCT06000111


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