Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06000111

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

Led by St. Joseph's Healthcare Hamilton · Updated on 2024-11-29

40

Participants Needed

1

Research Sites

110 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Consecutive patients with an idiopathic full-thickness macular hole
  • Symptom duration of less than 6 months
  • Patient must agree to participate in this investigation
Not Eligible

You will not qualify if you...

  • Macular hole minimum diameter greater than 1000 bcm
  • A history of high myopia (greater than -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

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

St. Joseph's Hospital King Campus

Stoney Creek, Ontario, Canada, L8G 5E4

Actively Recruiting

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Research Team

V

Varun Chaudhary, MD, FRCSC

CONTACT

K

Keean Nanji, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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