Blue Light Blocking for Heart Surgery Recovery

Overseen By James C Walton, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: West Virginia University

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

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether wearing blue light-blocking goggles at night aids recovery from certain heart surgeries. Researchers aim to determine if these goggles can reduce inflammation, improve mood and sleep, and prevent cognitive decline post-surgery. Participants will wear either blue light-blocking goggles or clear goggles during their hospital recovery. This trial suits individuals undergoing elective heart surgeries such as CABG, AVR, or MVR, who have no history of psychiatric disorders or organ failure. As an unphased trial, it offers participants the chance to contribute to innovative research that could enhance recovery for future heart surgery patients.

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 prior data suggests that blue light-blocking goggles are safe for post-surgical recovery?

Research shows that blue light-blocking lenses are safe for most people. These lenses often help reduce eyestrain and improve sleep. Studies suggest that using these goggles typically doesn't cause any serious issues. Most people tolerate them well and find them safe. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using blue light-blocking goggles for heart surgery recovery because they offer a non-invasive way to potentially improve sleep and recovery. Unlike traditional methods that might include medication for sleep or pain management, these goggles aim to enhance natural sleep patterns by filtering out blue light, which can interfere with sleep cycles. This approach is particularly promising because it relies on a simple change in the patient's environment rather than introducing new drugs, reducing the risk of side effects. It's an innovative step towards improving recovery through natural means, which could lead to faster healing and better outcomes for patients.

What evidence suggests that blue light-blocking goggles are effective for post-surgical recovery?

Research shows that wearing blue light-blocking goggles might improve sleep by reducing nighttime blue light exposure. Some studies suggest these goggles can lead to better sleep, although results vary. In this trial, participants recovering from heart surgeries will be assigned to different treatment arms. One group will receive blue light-blocking goggles, believed to aid recovery by promoting better sleep and potentially reducing inflammation. Another group will receive clear goggles as a placebo comparator. However, limited direct evidence shows significant benefits specifically for surgical recovery. Overall, the goggles may help by promoting better sleep, which is important for recovery. ^{2 3 4 6 7}

Who Is on the Research Team?

Randy J Nelson, PhD

Principal Investigator

West Virginia University

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Blue light-blocking goggles
• Clear goggles

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04578249

Effects of Blocking Blue Light At Night Post CABG, AVR ... Purpose The purpose of this study is to determine whether filtering out blue light at nighttime reduces post-surgical inflammation and/or moderates ...

2. withpower.com withpower.com/trial/phase-chronobiology-disorders-6-2021-58933

Blue Light Blocking for Heart Surgery Recovery There is likely little to no effect of blue-light filtering lenses on visual performance and sleep quality, with mixed results reported across studies ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10436683/

Blue‐light filtering spectacle lenses for visual performance ... Some claims exist that they can improve visual performance with digital device use, provide retinal protection, and promote sleep quality.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37593770/

Blue-light filtering spectacle lenses for visual performance, ... This systematic review found that blue-light filtering spectacle lenses may not attenuate symptoms of eye strain with computer use, over a short-term follow-up ...

5. researchgate.net researchgate.net/publication/312181395_Blue-Light_Filtering_Spectacle_Lenses_Optical_and_Clinical_Performances

Blue-Light Filtering Spectacle Lenses: Optical and Clinical ... Blue-light filtering spectacle lenses can partially filter high-energy short-wavelength light without substantially degrading visual performance and sleep ...

6. centerwatch.com centerwatch.com/clinical-trials/listings/NCT04578249/effects-of-blocking-blue-light-at-night-post-cabg-avr-mvr-cabg-avr-cabg-mvr-or-sah

Effects of Blocking Blue Light At Night Post CABG, AVR ... Purpose The purpose of this study is to determine whether filtering out blue light at nighttime reduces post-surgical inflammation and/or ...

7. mayoclinichealthsystem.org mayoclinichealthsystem.org/hometown-health/speaking-of-health/are-blue-light-blocking-glasses-a-must-have

Are blue light-blocking glasses a must-have? No significant improvement in vision performance or sleep quality has been found from using blue-blocking lenses.