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

NCT ID: NCT06000111

Last Updated: 2024-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-21

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Macular Holes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
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.

Study Groups

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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.

Group Type EXPERIMENTAL

3 Days of face-down positioning

Intervention Type 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 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.

Group Type ACTIVE_COMPARATOR

7 Days of face-down positioning

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role lead

Responsible Party

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Varun Chaudhary

Professor, Department of Surgery, Chief of Ophthalmology, Hamilton Regional Eye Institute

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Varun Chaudhary, MD, FRCSC

Role: PRINCIPAL_INVESTIGATOR

McMaster University, St. Joseph's Hospital

Locations

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St. Joseph's Hospital King Campus

Stoney Creek, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Varun Chaudhary, MD, FRCSC

Role: CONTACT

[email protected]
905-573-7777 ext. 38058

Keean Nanji, MD

Role: CONTACT

[email protected]
905-573-4848

Facility Contacts

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Keean Nanji, MD

Role: primary

[email protected]
6474575454

References

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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.

Reference Type DERIVED
PMID: 39163327 (View on PubMed)

Other Identifiers

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16100

Identifier Type: -

Identifier Source: org_study_id