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NCT Number: NCT06000111

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

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.

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Key information

Conditions

Macular Holes Eye Diseases Retinal Diseases Retinal Perforations

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Hospital King Campus

Stoney Creek, Ontario, L8G 5E4, Canada

Location status: Recruiting

Location contact

Keean Nanji, MD

CONTACT

[email protected]

6474575454

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

3 Days of face-down positioning

Behavioral

Following surgical repair, patients in the intervention group will maintain 3-days and nights of face-down positioning post-operatively.

7 Days of face-down positioning

Behavioral

Following surgical repair, patients in the intervention group will maintain 7-days and nights of face-down positioning post-operatively.

Primary outcomes

  1. Recruitment Rate

    Time frame: The recruitment rate will be calculated during the recruitment period.

    This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.

  2. Retention Rate

    Time frame: The retention rate will be calculated at 3-months post-operatively.

    This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.

  3. Completion Rate

    Time frame: The completion rate will be calculated at 3-months post-operatively.

    This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.

  4. Recruitment Time

    Time frame: The recruitment time will be calculated during the recruitment period.

    This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.

Secondary outcomes

  1. Macular Hole Closure Rate

    Time frame: 3-months post-operatively

    The rate of macular hole closure will be evaluated by 2-independent readers masked to treatment allocation. They will grade the outcome as open or closed. Outcomes classified as open will be further divided into open and flat (without a cuff of subretinal fluid) or open and elevated (with a cuff of subretinal fluid).

  2. Best-Corrected Visual Acuity (BCVA)

    Time frame: 3-months post-operatively

    Patient best-corrected visual acuity will be measured by Snellen visual acuity. With this measure of visual acuity, visual acuity can range from 20/10 (best) to 20/1000 (worst). If the patient is unable to read the chart at any distance, patients will next be assessed whether they can count figures at a given distance, if not, they will be tested to see whether they can perceive hand motion and if not, if they can perceive any light.

  3. Vision specific quality of life measure

    Time frame: 3-months post-operatively

    The National Eye Institute Visual Function Questionnaire (NEI VFQ-25) will be administered to patients. Possible patient scores range from 0 to 100 with a higher score representing higher vision-related quality of life.

  4. 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.

    Compliance will be assessed with self-administered questionnaires assessing the patients' compliance during the morning, midday, evening, and overnight. The possible range of scores is from 1 to 10 with higher scores indicating better compliance.

  5. Complication Rates

    Time frame: Rates will be determined for the entire follow-up period (3-months)

    Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage

  6. Health Related Quality of Life Measure

    Time frame: 3-months post-operatively

    The Quality of Life Scale (QOLS) will be administered to patients. The range of possible patient scores is from 16 to 112. Higher scores indicate higher quality of life.

Study contacts

Contact information is provided by the study sponsor or research team.

Keean Nanji, MD

CONTACT

[email protected]

905-573-4848

Varun Chaudhary, MD, FRCSC

CONTACT

[email protected]

905-573-7777 ext. 38058

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Aug 21, 2023
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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