Blue Light Blocking for Heart Surgery Recovery

Overseen by Randy J Nelson, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: West Virginia University

Disqualifiers: Dementia, Psychiatric disorder, Organ failure, COPD, others

Trial Summary

What is the purpose of this trial?

Purpose The purpose of this study is to determine whether filtering out blue light at nighttime reduces post-surgical inflammation and/or moderates cognitive decline and mood and sleep alterations in patients undergoing elective CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery. If manipulating nighttime light in hospital rooms improves patient outcomes, then it would be a relatively easy and inexpensive innovation that could reduce post-surgical complications and save millions of dollars per year in health care costs by shortening the length of hospital stays and reducing morbidity. The investigators aim to determine the relationship between inflammation and cognitive dysfunction after cardiac surgery.

Will I have to stop taking my current medications?

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 Blue light-blocking goggles for heart surgery recovery?

Research suggests that blue light-blocking lenses can improve sleep quality and protect the eyes from harmful light, which might indirectly support recovery by promoting better rest and reducing eye strain. ^{1 2 3 4 5}

Are blue light blocking lenses safe for humans?

Research on blue light blocking lenses, often used to reduce eyestrain and improve sleep, shows no significant safety concerns for general use in humans. ^{1 5 6 7 8}

How does blue light blocking help in heart surgery recovery?

Blue light blocking is unique because it involves filtering out blue light, which is thought to improve sleep quality and potentially aid in recovery. This approach is different from traditional treatments that focus on medications or physical therapies, as it targets light exposure to influence recovery outcomes. ^{1 2 4 9 10}

Research Team

Randy J Nelson, PhD

Principal Investigator

West Virginia University

Eligibility Criteria

This trial is for men and women without psychiatric disorders or organ failure, who are scheduled for elective heart surgeries like CABG, AVR, MVR, or SAH. Participants should not have a history of cardiac surgery, clotting disorders, severe lung disease (COPD), acute infections, cognitive deficits like dementia, immune disorders or conditions that may require blood transfusion during/after surgery.

Inclusion Criteria

I have no diagnosed psychiatric disorders or organ failure.

I am scheduled for a non-emergency heart surgery that involves a heart-lung machine.

Exclusion Criteria

You have been diagnosed with dementia or other memory problems.

I am undergoing or have undergone multiple heart surgeries at once.

I have an immune system disorder.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to wear either clear goggles or blue-light blocking goggles at night during their hospital recovery post-surgery

5 days

In-hospital stay

Follow-up

Participants are monitored for changes in cognitive function, inflammation, mood, and sleep quality post-surgery

30 days

Treatment Details

Interventions

• Blue light-blocking goggles (Behavioural Intervention)
• Clear goggles (Behavioural Intervention)

Trial Overview The study tests if wearing blue light-blocking goggles at night after certain heart surgeries can reduce inflammation and improve mood, sleep quality and prevent cognitive decline. It compares the effects with clear goggles to see if blocking blue light leads to better recovery outcomes.

Participant Groups

Group I: Blue-light blocking goggles Experimental Treatment 1 Intervention

Patients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given blue-light blocking goggles to wear at nighttime.

Group II: Clear goggles Placebo Group 1 Intervention

Patients recovering from CABG, AVR, MVR, CABG AVR, CABG MVR, or SAH surgery will be given clear goggles to wear at nighttime.

Who Is Running the Clinical Trial?

West Virginia University

Lead Sponsor

Trials

192

Recruited

64,700+

Dr. William P. Petros

West Virginia University

Chief Medical Officer

PharmD from West Virginia University

Dr. Clay B. Marsh

West Virginia University

Chief Executive Officer since 2015

MD from West Virginia University, Bachelor’s in Biology from West Virginia University

Findings from Research

Blue-light filtering spectacle lenses do not significantly reduce visual fatigue or improve critical flicker-fusion frequency compared to non-blue-light filtering lenses, based on a systematic review of 17 randomized controlled trials involving various adult populations.

There is likely little to no effect of blue-light filtering lenses on visual performance and sleep quality, with mixed results reported across studies, indicating a need for further high-quality research to clarify these effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults. Singh, S., Keller, PR., Busija, L., et al.[2023]

In a study of 11,028 patients who underwent cataract surgery, blue-light filtering intraocular lenses (BLF IOLs) were associated with better glaucoma-free survival and fewer glaucoma procedures compared to non-BLF IOLs, indicating their potential benefit in preventing glaucoma development.

However, for patients who already had glaucoma before surgery, there was no significant advantage in using BLF IOLs, suggesting that their protective effects are more pronounced in patients without preexisting glaucoma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effect of Blue-Light Filtering Intraocular Lenses on the Development and Progression of Glaucoma. Hecht, I., Kanclerz, P., Achiron, A., et al.[2023]

In a randomized clinical trial involving 60 patients, blue light-filter intraocular lenses (IOLs) did not hinder the surgeon's ability to perform vitreoretinal procedures, indicating their safety in surgical settings.

Both blue light-filter and ultraviolet-filter IOLs resulted in similar functional outcomes for patients, including visual acuity and contrast sensitivity, suggesting that blue light-filter IOLs can be routinely used without compromising patient results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. Falkner-Radler, CI., Benesch, T., Binder, S.[2015]

In a study of 93 patients who received a blue-blocking intraocular lens (Acrysof Natural) for cataract surgery, there were no significant differences in visual acuity, contrast sensitivity, or color vision compared to conventional intraocular lenses.

Most patients reported no noticeable difference in visual function between the Acrysof Natural IOL and conventional IOLs, suggesting that the blue-blocking lens can be safely used without compromising visual performance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of visual function following implantation of Acrysof Natural intraocular lenses with conventional intraocular lenses. Landers, J., Tan, TH., Yuen, J., et al.[2016]

The study evaluated 20 different commercially available filter glasses designed to protect users from blue light emitted by visible light-curing units, measuring their effectiveness in reducing light intensity.

Irradiance measurements from eight curing units showed that the reduction in blue light exposure through these glasses correlates with their specific transmission curves, highlighting the importance of selecting appropriate protective eyewear for safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of light transmission characteristics of protective eyeglasses for visible light-curing units. Fan, PL., Wozniak, WT., McGill, S., et al.[2019]

Wearing blue-blocking lenses (BBLs) in the evening may not effectively improve sleep quality, as they can still allow some blue light to pass through, which can suppress melatonin production.

Different brands of BBLs vary significantly in their effectiveness at blocking blue light, with those that block the most blue light showing the least impact on nocturnal melatonin secretion, suggesting that not all BBLs are equally beneficial for maintaining a healthy circadian rhythm.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modelling the effect of light through commercially available blue-blocking lenses on the human circadian system. Alzahrani, HS., Khuu, SK., Roy, M.[2022]

A review of three randomized controlled trials involving 136 participants found no significant benefits of blue-blocking (BB) spectacle lenses over standard lenses in improving visual performance, alleviating eyestrain, or enhancing sleep quality.

While one study noted a small improvement in sleep quality for individuals with insomnia using high BB lenses, overall evidence does not support the effectiveness of BB lenses for the general population in terms of visual performance or macular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of blue-light blocking spectacle lenses on visual performance, macular health and the sleep-wake cycle: a systematic review of the literature. Lawrenson, JG., Hull, CC., Downie, LE.[2022]

Blue-blocking lenses (BBLs) can significantly reduce blue light exposure (by 6-43%) and provide protection against photochemical retinal damage compared to standard lenses, based on a study evaluating seven types of BBLs.

BBLs also decrease blue color perception, scotopic vision sensitivity, and circadian rhythm sensitivity by varying percentages (5-36%, 5-24%, and 4-27% respectively), indicating their potential impact on both visual and non-visual functions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Modelling the effect of commercially available blue-blocking lenses on visual and non-visual functions. Alzahrani, HS., Khuu, SK., Roy, M.[2021]

A comprehensive review of 56 studies found that blue-blocking intraocular lenses (IOLs) do not significantly affect visual performance metrics such as visual acuity, contrast sensitivity, and color perception, with 91% of studies reporting no significant effects.

While there are concerns about potential negative impacts of blue-blocking IOLs on scotopic vision and sleep patterns, these effects appear minimal and clinically insignificant according to the majority of research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blue-blocking IOLs: a complete review of the literature. Henderson, BA., Grimes, KJ.[2019]

Cataract surgery with the implantation of a clear, UV-blocking intra-ocular lens (IOL) significantly improved patients' visual function and sleep quality, particularly in those who were poor sleepers before the surgery, as measured by the VFQ-25 and PSQI scores.

Despite improvements in sleep quality and visual function, the surgery did not result in significant changes in gait speed or metabolic health parameters over the 7-month follow-up period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rejuvenation effects of cataract surgery with ultraviolet blocking intra-ocular lens on circadian rhythm and gait speed. Ayaki, M., Negishi, K., Tsubota, K.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Blue-light filtering spectacle lenses for visual performance, sleep, and macular health in adults. [2023]

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

The Effect of Blue-Light Filtering Intraocular Lenses on the Development and Progression of Glaucoma. [2023]

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

Blue light-filter intraocular lenses in vitrectomy combined with cataract surgery: results of a randomized controlled clinical trial. [2015]

4. Australia pubmed.ncbi.nlm.nih.gov

Comparison of visual function following implantation of Acrysof Natural intraocular lenses with conventional intraocular lenses. [2016]

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

Evaluation of light transmission characteristics of protective eyeglasses for visible light-curing units. [2019]

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

Modelling the effect of light through commercially available blue-blocking lenses on the human circadian system. [2022]

7. England pubmed.ncbi.nlm.nih.gov

The effect of blue-light blocking spectacle lenses on visual performance, macular health and the sleep-wake cycle: a systematic review of the literature. [2022]

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

Modelling the effect of commercially available blue-blocking lenses on visual and non-visual functions. [2021]

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

Blue-blocking IOLs: a complete review of the literature. [2019]

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

Rejuvenation effects of cataract surgery with ultraviolet blocking intra-ocular lens on circadian rhythm and gait speed. [2022]