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

NCT06000111 | Recruiting

• 1 other identifier: 16100
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Macular Holes

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Macular Hole Closure Rate

  3-months post-operatively

• Best-Corrected Visual Acuity (BCVA)

  3-months post-operatively

• Vision specific quality of life measure

  3-months post-operatively

• Compliance with Face Down Positioning

  While the patient is positioning; this will either be for 3 days or 7 days depending on their treatment allocation.

• Complication Rates

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

Study Arms (2)

Face-Down Positioning for 3-Days and Nights

EXPERIMENTAL

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

Face-Down Positioning for 7-Days and Nights

ACTIVE COMPARATOR

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

Interventions

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.

Face-Down Positioning for 3-Days and Nights

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.

Face-Down Positioning for 7-Days and Nights

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Consecutive patients with an idiopathic full-thickness macular hole
• Symptom duration of less than 6 months
• Patient must agree to participate in this investigation

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Hospital King Campus

Stoney Creek, Ontario, L8G 5E4, Canada

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Retinal Perforations

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases

Study Officials

• Varun Chaudhary, MD, FRCSC

  McMaster University, St. Joseph's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Varun Chaudhary, MD, FRCSC

CONTACT

905-573-7777; vchaudh@mcmaster.ca

Keean Nanji, MD

CONTACT

905-573-4848; Keean.Nanji@medportal.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The surgeon will be masked to the patient's treatment allocation until after surgery is complete. At this point, the surgeon will be made aware of the patient's treatment allocation and inform the patient in the recovery room regarding their treatment allocation. The participants and the clinical teams managing the patient care will be unmasked. The outcome assessors will be masked.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Surgery, Chief of Ophthalmology, Hamilton Regional Eye Institute

Model Details: This study will be a single-centered, parallel group randomized controlled feasibility trial. Patients will be randomized 1:1 between groups.

Study Record Dates

• First Submitted: July 24, 2023
• First Posted: August 21, 2023
• Study Start: November 21, 2023
• Primary Completion: May 15, 2025
• Study Completion: December 31, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)