NCT03911596

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Mar 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 9, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2022

Completed
Last Updated

April 19, 2024

Status Verified

November 1, 2022

Enrollment Period

3.8 years

First QC Date

April 9, 2019

Last Update Submit

April 17, 2024

Conditions

Presbyopia

Keywords

Presbyopia, accommodation, smart eyeglasses

Outcome Measures

Primary Outcomes (1)

  • Accommodation response of the natural lens of the eye with smart eyeglasses technology

    60 minutes

Interventions

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.

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any individual above 45 years of age with symptoms of presbyopia.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Moran Eye Center, University of Utah

Salt Lake City, Utah, 84112, United States

Location

Related 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.

    PMID: 28158006BACKGROUND

  • 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.

    PMID: 32773917BACKGROUND

  • 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.

    BACKGROUND

MeSH Terms

Conditions

Presbyopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Officials

  • Carlos H Mastrangelo, PhD

    University of Utah

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 9, 2019

First Posted

April 11, 2019

Study Start

March 1, 2019

Primary Completion

December 30, 2022

Study Completion

December 30, 2022

Last Updated

April 19, 2024

Record last verified: 2022-11

Locations

US(1)