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

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.

Study Overview

• Status: Recruiting
• Conditions: Macular Holes
• Intervention / Treatment: Behavioral: 3 Days of face-down positioning; Behavioral: 7 Days of face-down positioning

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Varun Chaudhary, MD, FRCSC; Phone Number: 38058 905-573-7777; Email: vchaudh@mcmaster.ca
• Study Contact Backup: Name: Keean Nanji, MD; Phone Number: 905-573-4848; Email: Keean.Nanji@medportal.ca

Study Locations

• Canada
  • Ontario
    • Stoney Creek, Ontario, Canada, L8G 5E4
      • Recruiting
      • St. Joseph's Hospital King Campus
      • Contact: Keean Nanji, MD; Phone Number: 6474575454; Email: Keean.Nanji@medportal.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Face-Down Positioning for 3-Days and Nights; Patients allocated to this study arm will maintain face-down positioning for 3-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.	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.
Active Comparator: Face-Down Positioning for 7-Days and Nights; Patients allocated to this study arm will maintain face-down positioning for 7-days and nights post-operatively. Patients will be advised to posture immediately following surgery and will be advised to posture for 50 minutes of each hour. Patients will be advised that during their 10-minute break each hour, they should avoid face-up positioning. FDP will be advised during both waking and sleeping hours.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment Rate	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment rate of this study.	The recruitment rate will be calculated during the recruitment period.
Retention Rate	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the retention rate of this study.	The retention rate will be calculated at 3-months post-operatively.
Completion Rate	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the completion rate of this study.	The completion rate will be calculated at 3-months post-operatively.
Recruitment Time	This investigation's primary objective will be focused on assessing feasibility. One primary outcome will be to evaluate the recruitment time for this study.	The recruitment time will be calculated during the recruitment period.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Macular Hole Closure Rate	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).	3-months post-operatively
Vision specific quality of life measure	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.	3-months post-operatively
Complication Rates	Specifically, the rates of endophthalmitis, retinal detachment, and vitreous hemorrhage	Rates will be determined for the entire follow-up period (3-months)
Health Related Quality of Life Measure	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.	3-months post-operatively
Best-Corrected Visual Acuity (BCVA)	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-months post-operatively
Compliance with Face Down Positioning	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.	While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Varun Chaudhary, MD, FRCSC, McMaster University, St. Joseph's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): May 15, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: August 13, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 21, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Retinal Perforations
• Other Study ID Numbers: 16100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data may be shared with other researchers upon reasonable request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No