Face-Down Positioning Duration for Macular Hole Repair

Overseen By Keean Nanji, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: St. Joseph's Healthcare Hamilton

Disqualifiers: High myopia, Amblyopia, Retinal tear, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 1 week

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the optimal duration for patients to remain in a face-down position after surgery to repair a full-thickness macular hole, a gap in the retina's center. The study compares two groups: one group will lie face down for 3 days and nights, and the other for 7 days and nights, to determine which duration more effectively aids healing and vision improvement. Researchers aim to identify the best duration for face-down positioning in terms of healing and overall patient experience. This trial is suitable for individuals who have experienced symptoms of an idiopathic full-thickness macular hole for less than 6 months and are willing to adhere to the face-down positioning instructions. As an unphased trial, it offers patients the chance to contribute to valuable research that could enhance post-surgery recovery protocols.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this face-down positioning is safe for macular hole repair?

Research has shown that lying face down after macular hole surgery is generally safe. Studies indicate that each additional day in this position can increase the chances of successful healing. Patients have completed both 3-day and 7-day face-down periods without major side effects.

For the 3-day period, evidence suggests it might not significantly impact the closing of the macular hole, a small gap in the retina. In contrast, the 7-day period has demonstrated a high success rate for closing the hole, with some studies reporting a 100% closure rate in certain cases.

Overall, both 3-day and 7-day face-down positions are safe and can aid recovery after surgery, though their impact on healing may vary. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores whether a shorter duration of face-down positioning, just 3 days instead of the standard 7 days, might be effective for macular hole repair. Most current treatments require patients to maintain this uncomfortable face-down position for a full week to help the eye heal properly after surgery. By potentially reducing the time spent in this position, patients could experience greater comfort and convenience, which could lead to improved adherence to post-operative instructions and possibly faster recovery times. This investigation could redefine the post-operative care protocol, making the recovery process less burdensome for patients.

What evidence suggests that this trial's face-down positioning durations could be effective for macular hole repair?

This trial will compare two durations of face-down positioning after macular hole surgery: three days and seven days. Studies have shown that lying face-down for three days can successfully close the hole, significantly improving vision clarity. Another study suggested that some patients might not need to lie face-down at all to achieve good results. For the seven-day face-down positioning, research suggests slight improvements, but the evidence remains weak. Some findings indicate that the extra days might not offer more benefits than the shorter duration. Overall, both time frames can lead to positive results, but shorter positioning might be just as effective for many patients. ^{1 6 7 8 9}

Who Is on the Research Team?

Varun Chaudhary, MD, FRCSC

Principal Investigator

McMaster University, St. Joseph's Hospital

Are You a Good Fit for This Trial?

This trial is for patients with a recent (less than 6 months) idiopathic full-thickness macular hole. Participants must agree to follow the study procedures, which include lying face down for several days after eye surgery.

Inclusion Criteria

You have consented to take part in this study.

My symptoms started less than 6 months ago.

I have a macular hole in my eye not caused by known diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo pars plana vitrectomy surgery followed by face-down positioning for either 3 or 7 days and nights

1 week

Post-operative visits as needed

Follow-up

Participants are monitored for macular hole closure, visual acuity, quality of life, and complications

3 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• 3 Days of face-down positioning
• 7 Days of face-down positioning

Trial Overview

The study compares two different durations of face-down positioning—3 days versus 7 days—after vitrectomy surgery to repair a macular hole in the retina. It aims to determine which duration is more effective and feasible.

How Is the Trial Designed?

Group I: Face-Down Positioning for 3-Days and Nights Experimental Treatment 1 Intervention

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 II: Face-Down Positioning for 7-Days and Nights Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

St. Joseph's Healthcare Hamilton

Lead Sponsor

Trials

203

Recruited

26,900+

Published Research Related to This Trial

In a study of 115 patients with idiopathic macular holes, anatomical success was achieved in 94% of cases without the need for postoperative face-down positioning, suggesting a less burdensome recovery process for patients.

Both small and large macular holes showed significant improvement in visual acuity post-surgery, with an average gain of 3 lines for small holes and 7 lines for large holes, indicating effective surgical outcomes comparable to traditional methods that require face-down positioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular hole repair: the effect of size and nonsupine posture on postoperative outcomes. Berco, E., Tuli, R., Sivachandran, N., et al.[2023]

In a study of 50 patients with Stage 2 or Stage 3 idiopathic macular holes, a short 3-day face-down positioning after vitrectomy surgery resulted in a high anatomical closure rate of 98%.

The procedure also led to a significant improvement in visual acuity, with an average decrease of 0.271 in the logarithm of the minimum angle of resolution, indicating better vision post-surgery and minimal complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anatomical and visual outcomes of macular hole surgery with short-duration 3-day face-down positioning. Almeida, DR., Wong, J., Belliveau, M., et al.[2012]

A pilot study involving 33 patients with varying stages of macular holes found that successful closure can be achieved without the need for face-down positioning, suggesting a more convenient option for patients who cannot maintain this posture.

The overall success rate for macular hole repair was 79% after one surgery and 85% with additional procedures, indicating that effective treatment is possible even without traditional face-down recovery methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Macular hole surgery without face-down positioning. A pilot study. Tornambe, PE., Poliner, LS., Grote, K.[2022]

In a study of 53 patients with full thickness macular holes, shortening the required face-down positioning after surgery from 7 days to 3 days did not significantly affect the success rate of macular hole closure, with closure rates of 93.1% and 87.5% respectively.

The findings suggest that 3 days of strict face-down positioning is sufficient for achieving closure of macular holes, even those that have been present for over a year, indicating a potential for improved patient comfort without compromising surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Duration of face-down positioning after macular hole surgery: a comparison between 1 week and 3 days. Krohn, J.[2022]

A study involving 55 patients compared two groups after macular hole surgery: one group maintained a prone position for one week, while the other group only for 24 hours.

The initial hole closure rates were similar between the two groups (91.2% for one week and 90.5% for one day), suggesting that the prone positioning duration can be safely reduced to just 24 hours without compromising surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Shortening the duration of prone positioning after macular hole surgery--comparison between one week and one day]. Isomae, T., Sato, Y., Shimada, H.[2015]

Patients who underwent macular hole surgery with nonsupine positioning achieved similar anatomical success rates (100% closure) compared to those who followed strict face-down positioning (96% closure), indicating that less stringent positioning may be just as effective.

A majority of patients (100% of the nonsupine group vs. 51% of the face-down group) preferred the nonsupine positioning for potential repeat surgeries, highlighting the importance of patient comfort in postoperative care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nonsupine positioning is preferred by patients over face-down positioning and provides an equivalent closure rate in 25- and 23-gauge macular hole surgery. Feist, RM., Pomerleau, DL., Feist, R., et al.[2015]

A review of 17 studies on face-down posturing after macular hole surgery found no significant difference in closure rates between those who postured for 24 hours or less and those who postured for 5-10 days, indicating that the duration may not critically affect surgical outcomes.

The analysis highlighted the need for higher-quality studies, as the current evidence is insufficient to draw firm conclusions about the impact of posturing duration on visual acuity improvement or anatomical success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Face-down posturing after macular hole surgery: a meta-analysis. Tatham, A., Banerjee, S.[2017]

Citations

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Duration of face-down positioning after macular hole surgery

Thus, the results indicate that 3 days of strict face-down positioning are sufficient to achieve closure of even longstanding macular holes without removal of

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Facedown Positioning in Macular Hole Surgery

Across all trials, visual acuity at 6 months or the nearest timepoint improved on average by –0.38 logMAR (standard deviation, 0.28, P < 0.001) ...

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Face‐down positioning or posturing after macular hole surgery

Following surgery for macular hole, a period of face‐down positioning for up to two weeks may be advised with the aim of improving the likelihood of successful ...

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Macular hole repair does not require face-down positioning

Overall, 56 of 68 eyes achieved best corrected visual acuity (BCVA) of 20/50 or better at last follow-up. Of the 61 eyes that completed at least three months' ...

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nature.com

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A study on postural care after macular hole surgery based ...

The cumulative time in the effective prone position was recorded. Among 18 included participants, the mean total effective face-down position ( ...

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Face-down positioning or posturing after macular hole ...

Low-certainty evidence suggests that face-down positioning may have little or no effect on macular hole closure after surgery.

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Face‐down positioning or posturing after macular hole ...

Overall, when we compared face‐down positioning to non‐face‐down positioning, there may be no positive effect on hole closure with face‐down positioning.

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Face-Down Positioning After PPV May Be Most Beneficial ...

Based on linear analysis of data from 3, 5, and 10 days of FDP, each additional day of FDP was associated with improved odds of full-thickness ...

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What are the benefits and risks of face-down positioning ...

Low-certainty evidence suggests that face-down positioning may have little or no effect on macular hole closure after surgery. Face-down ...