Multiplexing Prism for Monocular Vision

Overseen By Eli Peli, OD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts Eye and Ear Infirmary

Disqualifiers: Cognitive dysfunction, Balance problems, Others

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

Compensation: Varies

Number of Visits: 3

Duration: 4 months

Trial Summary

What is the purpose of this trial?

The investigators are developing an assistive device, known as multiplexing prism that expands the field of view for individuals with acquired monocular vision (loss of an eye). The investigators will test the efficacy of the prism in improving the detection of colliding pedestrians during a simulated walking task.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Multiplexing Prism for Monocular Vision (also known as: Multiplexing Prism, Multiplexing Prism, MxP) is an effective treatment?

The available research shows that Multiplexing Prism (MxP) glasses are effective for people with acquired monocular vision. Specifically, the study on field expansion with MxP glasses found that they help improve the ability to detect potential hazards while walking, which is important for safety. This suggests that MxP glasses can effectively expand the visual field for those who have lost vision on one side, making it easier for them to navigate their environment. ^{1 2 3 4 5}

What safety data exists for the Multiplexing Prism treatment?

The provided research does not contain any safety data for the Multiplexing Prism treatment. The studies focus on the evaluation of different autorefractors and photoscreeners for detecting refractive errors and amblyogenic risk factors, but do not mention the Multiplexing Prism or related treatments. ^{6 7 8 9 10}

Is the Multiplexing Prism a promising treatment for people with vision in only one eye?

Yes, the Multiplexing Prism is a promising treatment for people with vision in only one eye. It helps expand their field of vision, making it easier to detect potential hazards, especially when walking. ^{2 3 11 12 13}

Research Team

Eli Peli, OD

Principal Investigator

Schepens Eye Research Institute

Eligibility Criteria

This trial is for individuals who have lost vision in one eye (with no light perception) for over a year, but have good corrected visual acuity better than 20/32 and no field defects in their seeing eye. They should not have health issues like seizures or motor movement problems.

Inclusion Criteria

I have been blind in one eye for more than a year.

I do not have seizures or problems with motor movements.

My corrected vision in my seeing eye is better than 20/32.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants perform a simulated walking task with and without the multiplexing prism to test its efficacy in improving detection of colliding pedestrians

4 months

Approximately 3 sessions, up to 3 hours each

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Multiplexing Prism

Trial Overview The study is testing a device called multiplexing prism designed to widen the field of view for people with monocular vision. Its effectiveness will be evaluated through a simulated walking task to see if it helps detect pedestrians that could collide with them.

Participant Groups

Group I: Detection of colliding pedestrian Experimental Treatment 1 Intervention

Participants will perform a simulated walking task in which surrounding pedestrians will walk towards and make a collision. Participants will respond by pressing buttons to indicate the direction of the colliding pedestrians. Participants will perform the task with and without the multiplexing prism in random orders.

Who Is Running the Clinical Trial?

Massachusetts Eye and Ear Infirmary

Lead Sponsor

Trials

115

Recruited

15,000+

National Eye Institute (NEI)

Collaborator

Trials

572

Recruited

1,320,000+

Findings from Research

In a case series involving 12 patients with stable diplopia due to acquired strabismus, extreme pseudophakic monovision significantly reduced or eliminated double vision after cataract surgery.

This approach involved targeting one eye for clear distance vision and the other for myopia, resulting in excellent uncorrected vision for both distance and near tasks, suggesting a potential new strategy for managing diplopia in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intentional extreme anisometropic pseudophakic monovision: new approach to the cataract patient with longstanding diplopia. Osher, RH., Golnik, KC., Barrett, G., et al.[2013]

The newly developed multiplexing prism (MxP) effectively expands the visual field for monocular patients by overcoming the limitations of apical scotomas, which conventional prisms cannot address.

Preliminary evaluations show that MxPs can significantly increase the nasal visual field in patients with conditions like hemianopia, suggesting a promising and cost-effective solution for enhancing vision in those with visual field loss.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multiplexing Prisms for Field Expansion. Peli, E., Jung, JH.[2022]

The base-in multiplexing prism (MxP) glasses significantly improved the ability of patients with acquired monocular vision (AMV) to detect pedestrians approaching from their blind side, providing a true field expansion of about 25°.

In a virtual reality walking environment, participants with simulated AMV showed better pedestrian detection rates when using the MxP, indicating that these glasses could help reduce collision risks for individuals with AMV.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. Jung, JH., Castle, R., Kurukuti, NM., et al.[2023]

In a study of 94 patients with diplopia, 88% experienced complete or partial resolution of their double vision after being prescribed prisms, indicating high efficacy of this treatment method.

The most significant improvements were seen in patients with divergence insufficiency and skew deviation (100% resolution), while those with convergence insufficiency had a lower improvement rate of 64%.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of prisms in the management of diplopia in patients due to diverse etiologies. Tamhankar, MA., Ying, GS., Volpe, NJ.[2012]

In a study involving patients with age-related macular degeneration (AMD), the use of yoke prisms significantly improved best corrected visual acuity (BCVA) levels, indicating their efficacy in enhancing vision by redirecting images to preferred retinal loci (PRLs).

The distance BCVA achieved with prisms was nearly the same as the potential visual acuity (PVA), suggesting that prisms can effectively restore visual function in low vision cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Restitution of potential visual acuity in low vision patients with the use of yoke prisms. Markowitz, SN., Teplitsky, JE., Taheri-Shirazi, M.[2021]

In a study of 3170 children aged 6 months to 12 years, the Plusoptix Autorefractor A09 (POA09) detected refractive errors with varying reliability, identifying astigmatism and anisometropia more effectively than hyperopia and myopia.

The study found that while the POA09 had a detection rate of 60% for astigmatism and 53.3% for anisometropia, its overall reliability was limited without cycloplegia, suggesting that systematic amblyopia screening should include cycloplegic assessments for better accuracy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Detections of refractive risk factors for amblyopia with Plusoptix Autorefractor A09]. Al-Romhein, P., Fröhlich, M., Schmickler, S., et al.[2022]

The Retinomax K-plus2 and plusoptiX S08 autorefractors are effective in detecting myopia, astigmatism, and anisometropia in children, showing high sensitivity compared to cycloplegic retinoscopy, especially after cycloplegia.

However, both devices tend to underestimate hyperopia when not used with cycloplegia, indicating a limitation in their accuracy for detecting significant hyperopic refractive errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for refractive errors in children: the plusoptiX S08 and the Retinomax K-plus2 performed by a lay screener compared to cycloplegic retinoscopy. Paff, T., Oudesluys-Murphy, AM., Wolterbeek, R., et al.[2022]

The Welch Allyn SureSight autorefractor demonstrated high validity and repeatability in measuring peripheral refractive error, showing measurements closely aligned with the Grand Seiko WR-5100K, with no significant differences across various gaze angles.

In contrast, the Plusoptix PowerRefractor showed more myopic measurements and significant differences from the Grand Seiko in several gaze directions, indicating it may be less reliable for peripheral refractive assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Repeatability and Validity of Peripheral Refraction with Two Different Autorefractors. Morrison, AM., Mutti, DO.[2021]

The plusoptiX A12 device demonstrated high accuracy in detecting amblyogenic risk factors in children, with strong correlations in measurements of myopia and astigmatism, making it a reliable screening tool.

While the device showed excellent sensitivity and specificity for myopia (86% and 93%, respectively) and astigmatism (85% and 98%), its reliability was lower for hyperopia, indicating a potential underestimation of hyperopic refractive errors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A comparison of plusoptiX A12 measurements with cycloplegic refraction. Fogel-Levin, M., Doron, R., Wygnanski-Jaffe, T., et al.[2022]

In a study of 100 preschool children, the MTI photoscreener demonstrated higher data acquisition success (96%) compared to the Welch-Allyn SureSight autorefractor (76%), indicating better usability in a clinical setting.

While the SureSight showed comparable sensitivity to the MTI for detecting amblyogenic factors, its low specificity led to a high rate of over-referrals, suggesting that the MTI may be a more reliable option for accurate vision screening in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the MTI Photoscreener and the Welch-Allyn SureSight autorefractor in a tertiary care center. Rogers, DL., Neely, DE., Chapman, JB., et al.[2016]

Bifocal and trifocal designs for monovision corrections significantly enhance optical performance, providing a 5% improvement in optical quality and a 35% increase in through-focus usability compared to spherical aberration designs.

The study found that a bifocal design with a 1.5 diopter addition offers the best range of vision for near tasks, suggesting that combining monofocal and multifocal designs can optimize vision for individuals with presbyopia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Optical properties of monovision corrections using multifocal designs for near vision. de Gracia, P.[2018]

A new type of prism made from a combination of planoconvex and planoconcave cylindrical lenses can adjust its strength continuously from 0 to 90 prism diopters, making it very versatile for various optical applications.

The study explores how the angle at which light hits the prism affects its power, which is important for understanding how to use this new prism effectively in different situations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[A variable prism]. Zhou, W., Wang, JP.[2008]

The Biessels binocular prism loupe spectacles, developed in 1970, offer variable magnification up to 12 times and provide comfortable stereoscopic vision, making them superior to previous low vision aids like Galilean telescopic spectacles.

Over the past 7 years, more than 500 of these loupes have been successfully delivered to low vision patients, including 40 for microsurgery, demonstrating their efficacy and positive impact on users' visual capabilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The prism loupe spectacles used as low vision aid and in microsurgery (author's transl)]. Oosterhuis, JA., Biessels, WJ.[2009]

References

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

Intentional extreme anisometropic pseudophakic monovision: new approach to the cataract patient with longstanding diplopia. [2013]

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

Multiplexing Prisms for Field Expansion. [2022]

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

Field Expansion with Multiplexing Prism Glasses Improves Pedestrian Detection for Acquired Monocular Vision. [2023]

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

Effectiveness of prisms in the management of diplopia in patients due to diverse etiologies. [2012]

5. Spain pubmed.ncbi.nlm.nih.gov

Restitution of potential visual acuity in low vision patients with the use of yoke prisms. [2021]

6. Germany pubmed.ncbi.nlm.nih.gov

[Detections of refractive risk factors for amblyopia with Plusoptix Autorefractor A09]. [2022]

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

Screening for refractive errors in children: the plusoptiX S08 and the Retinomax K-plus2 performed by a lay screener compared to cycloplegic retinoscopy. [2022]

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

Repeatability and Validity of Peripheral Refraction with Two Different Autorefractors. [2021]

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

A comparison of plusoptiX A12 measurements with cycloplegic refraction. [2022]

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

Comparison of the MTI Photoscreener and the Welch-Allyn SureSight autorefractor in a tertiary care center. [2016]

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

Optical properties of monovision corrections using multifocal designs for near vision. [2018]

12. China pubmed.ncbi.nlm.nih.gov

[A variable prism]. [2008]

13. Germany pubmed.ncbi.nlm.nih.gov

[The prism loupe spectacles used as low vision aid and in microsurgery (author's transl)]. [2009]