Smart Autofocusing Eyeglasses

Presbyopia Clinical Trial

Official title:

Cyber Physical System for Smart Corrective Eyeglasses

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03911596
• Other study ID #: IRB # 114415
• Secondary ID: 5U01EB023048
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: December 30, 2022

Study information

• Verified date: November 2022
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: December 30, 2022
• Est. primary completion date: December 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Presbyopia

Intervention

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.

Locations

Country	Name	City	State
United States	Moran Eye Center, University of Utah	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

United States, 

References & Publications (3)

Hasan N, Banerjee A, Kim H, Mastrangelo CH. Tunable-focus lens for adaptive eyeglasses. Opt Express. 2017 Jan 23;25(2):1221-1233. doi: 10.1364/OE.25.001221. — View Citation

Hasan N, Karkhanis M, Ghosh C, Khan F, Ghosh T, Kim H, Mastrangelo CH. Lightweight Smart Autofocusing Eyeglasses. Proc SPIE Int Soc Opt Eng. 2018 Jan-Feb;10545:1054507. doi: 10.1117/12.2300737. Epub 2018 Feb 22. — View Citation

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accommodation response of the natural lens of the eye with smart eyeglasses technology		60 minutes