NCT06266728

T30 for Astigmatism in Digital Device Users

Performance of Total30 for Astigmatism in Digital Device Users

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (actual)
• Sponsor: Southern College of Optometry · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study aims to determine if Total30 lenses for astigmatism can be successfully fit in participants who are heavy digital device users.

Detailed description

Extensive computer use is no longer an employment-specific challenge. Use of digital devices in work, home, and leisure settings is now the norm, and it is now socially expected. While the introduction of high-powered computers and digital devices have greatly improved many aspects of modern life, the pervasive use of digital devices has caused some patients to develop a condition known as Digital Eye Strain (DES). DES has been reported to be as high as 93% the population depending upon how the condition is defined, and its severity has been found to increase with increased digital device time. DES is a condition where patients experience symptoms such as glare, accommodative dysfunction, defocus, fatigue, discomfort, and dryness from digital device use, and these dry eye symptoms may also result in decreased quality of life. While dryness symptoms in DES are likely multifactorial (e.g., contact lens use, systemic disease status), much of the dryness symptoms in DES are probably due to tear film evaporation secondary to having a reduced number of blinks per minute while using digital devices. Contact lens (CL) discomfort affects most CL wearers with discomfort consistently topping the reasons why established CL wearers drop out of CLs. In fact, studies have consistently found that the frequency of CL dropout is around 20% with this dropout frequency staying relatively stable over the past 20 plus years. This static frequency of CL dropout is surprising since there have been a number of dramatic soft CL innovations during this time frame (e.g., widely available daily disposable CLs, silicone hydrogel CL materials with high oxygen transmissibility, new CL surface coatings). CL discomfort and dropout could be affected by significant time spent on digital devices and DES. Maintaining ocular comfort with satisfactory CL performance (comfort, lack of dryness, and overall good vision) is key to overall success. This could be especially important in patients who wear astigmatic CLs, yet the community currently lacks data on this topic.

Conditions

• Contact Lens Complication
• Astigmatism
• Refractive Errors

Interventions

Type	Name	Description
DEVICE	Total30 for Astigmatism Contact Lenses	Participants must be refit into Total30 for Astigmatism Contact Lenses and wear them over the course of this one month study.

Timeline

• Start date: 2024-03-15
• Primary completion: 2024-08-15
• Completion: 2024-08-18
• First posted: 2024-02-20
• Last updated: 2025-02-24

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study