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

Trial Summary

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 data supports the effectiveness of the treatment 'Face-Down Positioning Duration for Macular Hole Repair'?

Research shows that shortening face-down positioning from 1 week to 3 days does not significantly affect the success rate of macular hole surgery. Additionally, some studies suggest that avoiding strict face-down positioning can still achieve similar closure rates, indicating flexibility in post-surgery positioning may be effective. ^{1 2 3 4 5}

Is face-down positioning after macular hole surgery safe for humans?

The research does not specifically address safety concerns, but it suggests that face-down positioning is challenging for patients, and alternatives are being explored to improve comfort without compromising surgical outcomes. ^{1 2 3 4 6}

How does face-down positioning duration for macular hole repair differ from other treatments?

Face-down positioning after macular hole surgery is unique because it involves patients lying face-down for a specific duration to help the hole heal. This treatment can vary in duration, with some studies suggesting shorter periods like 3 days may be as effective as longer periods like 7 days, making it potentially more comfortable and less burdensome for patients. ^{1 2 3 4 7}

What is the purpose of this trial?

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.

Research Team

Varun Chaudhary, MD, FRCSC

Principal Investigator

McMaster University, St. Joseph's Hospital

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Macular hole surgery without face-down positioning. A pilot study. [2022]

2. United States 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. [2015]

3. United States pubmed.ncbi.nlm.nih.gov

Anatomical and visual outcomes of macular hole surgery with short-duration 3-day face-down positioning. [2012]

4. Denmark pubmed.ncbi.nlm.nih.gov

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

5. England pubmed.ncbi.nlm.nih.gov

Face-down posturing after macular hole surgery: a meta-analysis. [2017]

6. Japan pubmed.ncbi.nlm.nih.gov

[Shortening the duration of prone positioning after macular hole surgery--comparison between one week and one day]. [2015]

7. United States pubmed.ncbi.nlm.nih.gov

Macular hole repair: the effect of size and nonsupine posture on postoperative outcomes. [2023]