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Smart Autofocusing Eyeglasses

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ClinicalTrials.gov Identifier: NCT03911596
Recruitment Status : Recruiting
First Posted : April 11, 2019
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Carlos Mastrangelo, University of Utah

Brief Summary:
A high-performance smart eyeglasses system with integrated sensing, actuation, control and data collection is being developed at the University of Utah. These smart eyeglasses use tunable lenses and integrated sensor technologies to correct blurred vision caused due to a major age-related condition called presbyopia.The objective of this study is to test this smart system on patients suffering from presbyopia aged 45 and above. The researchers intend to study the effect of these smart eyeglasses by qualitatively investigating the patient's visual acuity with this smart system. The results of this study and subsequent research have the potential to lead to major lifestyle improvements and better treatment for millions of presbyopic patients that are constrained by the limitation of current corrective eyeglass technologies. There are two main sources of fairly well understood problems that lead to presbyopia and loss of the eye focusing function. The adaptive eyeglasses used in these tests do not fix any of the internal eye problems. They just compensate externally for the loss of the eye focusing function caused by presbyopia. As such, the investigators intend to evaluate our system's effectiveness in terms of the sharpness of the perceived images.

Condition or disease Intervention/treatment
Presbyopia Device: Smart Autofocusing Eyeglasses

Detailed Description:

Eye defects occur when the eye cannot focus images from the outside world. This results in blurred vision, which sometimes is so severe that it causes visual impairment. Among the many vision defects, presbyopia is an inevitable, irreversible, universal age-related condition where the crystalline lens in the eye loses its accomodation orthe ability to change the optical power. This defect occurs as a natural result of aging and will ultimately affect any person reaching advanced enough age. It was estimated in 2005 that over 1 billion people worldwide suffered from presbyopia, with approximately 400 million suffering from near vision loss due to the lack of correction technologies.

The most inexpensive and commonly used tools to correct vision errors are fixed power eyeglasses, which haven't seen any improvement since the mid-1800s. Conventional eyeglasses are an ancient piece of technology which originated in Europe's middle ages. A major drawback of such eyeglasses is that they can only correct the lack of accomodation at a particular object distance, since they use fixed power lenses. As a result, conventional eyeglasses can produce sharp images for objects located either far away or near the observer but not both. Bifocal, multifocal and progressive lenses can partially alleviate vision defects, but at the expense of reduced and fragmented field of view. As an example, multifocal lenses have different lens powers in different regions of the lens. With such lenses, it is not possible to see objects clearly over the entire visual field. Further, the effectiveness of conventional eyeglasses is not monitored outside the optometrist's office.

The proposed smart eyeglasses system uses a combination of large-aperture fluidic lenses, ultra-light actuators, object distance sensors and embedded control, communications and computing electronics to continuously produce sharp and focused images at any object range. They can also collect the behaviour and characteristics of the observer's eyes to gauge the effectiveness of the technology and adapt to observer's visual degradation over age.


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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Cyber Physical System for Smart Corrective Eyeglasses
Actual Study Start Date : March 1, 2019
Estimated Primary Completion Date : August 2019
Estimated Study Completion Date : August 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eye Wear


Intervention Details:
  • Device: Smart Autofocusing Eyeglasses
    The smart eyeglasses system is meant to be a next generation alternative technology which replaces the generic eyeglasses used for correction of refractory defects in human vision. These smart eyeglasses do not fix any internal eye problems. They just externally compensate for the loss of eye focusing functions caused by presbyopia. This system is a medical assistive device which is meant to improve the quality of life of presbyopic patients.


Primary Outcome Measures :
  1. Accommodation response of the natural lens of the eye with smart eyeglasses technology [ Time Frame: 60 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any individual above 45 years of age with symptoms of presbyopia.
Criteria

Inclusion Criteria:

  • Presbyopic
  • Less than 1.0 diopter astigmatism
  • Eyeglass prescription between -2.5 and +2.5, correctable to 20/20

Exclusion Criteria:

  • Artificial intraocular lens
  • Any ocular pathology that would inhibit accommodation of the natural lens

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03911596


Contacts
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Contact: Carlos H Mastrangelo, PhD 801-587-7587 carlos.mastrangelo@utah.edu
Contact: Mohit U Karkhanis mohit.karkhanis@utah.edu

Locations
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United States, Utah
Moran Eye Center, University of Utah Recruiting
Salt Lake City, Utah, United States, 84112
Contact: Kelliann Farnsworth, Certified Ophthalmic Assistant    801-581-2352    kellian.farnsworth@hsc.utah.edu   
Contact: Mohit U Karkhanis       mohit.karkhanis@utah.edu   
Principal Investigator: Mohit U Karkhanis         
Sponsors and Collaborators
University of Utah
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
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Principal Investigator: Carlos H Mastrangelo, PhD University of Utah

Publications:
N. Hasan, M. Karkhanis, C. Ghosh, F. Khan, T. Ghosh, H. Kim, and C. H. Mastrangelo. Lightweight smart autofocusing eyeglasses. Proc. SPIE 10545, MOEMS and Miniaturized Systems XVII, 1054507 (22 February 2018); doi: 10.1117/12.2300737; https://doi.org/10.1117/12.2300737
N. Hasan, M. Karkhanis, F. Khan, T. Ghosh, H. Kim, and C. H. Mastrangelo. Adaptive Optics for Autofocusing Eyeglasses. Imaging and Applied Optics 2017 (3D, AIO, COSI, IS, MATH, pcAOP), OSA Technical Digest (online) (Optical Society of America, 2017), paper AM3A.1.

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Responsible Party: Carlos Mastrangelo, Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03911596     History of Changes
Other Study ID Numbers: IRB # 114415
5U01EB023048 ( U.S. NIH Grant/Contract )
First Posted: April 11, 2019    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Carlos Mastrangelo, University of Utah:
Presbyopia, accommodation, smart eyeglasses
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases