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Recruiting NCT06000111

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

No phase Interventional Macular Holes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 3 Days of face-down positioning, 7 Days of face-down positioning.
Who it may be relevant to
Registry conditions: Macular Holes. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Recruitment Rate [Time frame: The recruitment rate will be calculated during the recruitment period.]
  • Retention Rate [Time frame: The retention rate will be calculated at 3-months post-operatively.]
  • Completion Rate [Time frame: The completion rate will be calculated at 3-months post-operatively.]
  • Recruitment Time [Time frame: The recruitment time will be calculated during the recruitment period.]
Secondary outcome measures (6)
  • Macular Hole Closure Rate [Time frame: 3-months post-operatively]
  • Best-Corrected Visual Acuity (BCVA) [Time frame: 3-months post-operatively]
  • Vision specific quality of life measure [Time frame: 3-months post-operatively]
  • Compliance with Face Down Positioning [Time frame: While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.]
  • Complication Rates [Time frame: Rates will be determined for the entire follow-up period (3-months)]
  • Health Related Quality of Life Measure [Time frame: 3-months post-operatively]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Canada · 1 center
  • St. Joseph's Hospital King Campus — Stoney Creek

Publications

  • Nanji K, Oquendo PL, Srinivasan S, Vyas C, Prasad F, Farrokhyar F, Chaudhary V. Duration of face down positioning following full-thickness macular hole repair: A protocol for a randomized pilot study. PLoS One. 2024 Aug 20;19(8):e0304566. doi: 10.1371/journal.pone.0304566. eCollection 2024. PMID 39163327

Identifiers

NCT: NCT06000111 · 16100

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗