PresbyopiaNCT03911596
Smart Autofocusing Eyeglasses
An observational study of Presbyopia, run by University of Utah at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Presbyopia
- What is being tested?
- Smart Autofocusing Eyeglasses
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2019to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Any individual above 45 years of age with symptoms of presbyopia.
Who may be able to join
- Presbyopic
- Less than 1.0 diopter astigmatism
- Eyeglass prescription between -2.5 and +2.5, correctable to 20/20
Who cannot join
- Artificial intraocular lens
- Any ocular pathology that would inhibit accommodation of the natural lens
Trial locations and contacts
1 site in 1 country.
United States1 site
Moran Eye Center, University of Utah
Salt Lake City, Utah, 84112
About this study
Official title: Cyber Physical System for Smart Corrective Eyeglasses
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.
Read the 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.
- Conditions
- Presbyopia
- Being tested
- Smart Autofocusing Eyeglasses
- Keywords
- Presbyopia, accommodation, smart eyeglasses
- Medical subject headings
- Presbyopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smart Autofocusing EyeglassesDevice
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Accommodation response of the natural lens of the eye with smart eyeglasses technology
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start1 Mar 2019
- Primary completion30 Dec 2022
- Study completion30 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for PresbyopiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Responsible party
- Sponsor
- Investigators
- Carlos H Mastrangelo, PhD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03911596
- Sponsor's protocol ID
- IRB # 114415
- Other IDs
- 5U01EB023048
- Status last verified
- Nov 2022
- First submitted
- 9 Apr 2019
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 28158006Hasan 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.
PubMed 32773917N. 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyber Physical System for Smart Corrective Eyeglasses
- ClinicalTrials.gov ID
- NCT03911596
- Acronym / sponsor ID
- IRB # 114415
- Conditions
- Presbyopia
- Keywords
- Presbyopia, accommodation, smart eyeglasses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- National Institute for Biomedical Imaging and Bioengineering (NIBIB)
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 30 Dec 2022 (actual)
- Study completion
- 30 Dec 2022 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Any individual above 45 years of age with symptoms of presbyopia.
Key inclusion criteria (3 listed)
- Presbyopic
- Less than 1.0 diopter astigmatism
- Eyeglass prescription between -2.5 and +2.5, correctable to 20/20
Key exclusion criteria (2 listed)
- Artificial intraocular lens
- Any ocular pathology that would inhibit accommodation of the natural lens
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smart Autofocusing EyeglassesThe 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. | Device | – |
Primary outcome
Accommodation response of the natural lens of the eye with smart eyeglasses technology
Time frame: 60 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- Background: PubMed 28158006Hasan 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.
- Background: PubMed 32773917Hasan 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.
- BackgroundN. 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carlos H Mastrangelo, PhD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Presbyopia, run by University of Utah at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accommodation response of the natural lens of the eye with smart eyeglasses technology (time frame: 60 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03911596, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.