June 2023
Volume 64, Issue 8
Open Access
ARVO Annual Meeting Abstract  |   June 2023
Control of Myopia Using Diffusion Optics Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 42-month results
Author Affiliations & Notes
  • Thomas Chalberg
    SightGlass Vision Inc, Los Altos, California, United States
  • Deborah Laughton
    SightGlass Vision Inc, Los Altos, California, United States
  • Jennifer Hill
    SightGlass Vision Inc, Los Altos, California, United States
  • Vanessa Tasso
    SightGlass Vision Inc, Los Altos, California, United States
  • Graeme Young
    Visioncare Research Limited, Farnham, United Kingdom
  • Christopher Hunt
    Visioncare Research Limited, Farnham, United Kingdom
  • Jay Neitz
    University of Washington, Seattle, Washington, United States
  • Maureen Neitz
    University of Washington, Seattle, Washington, United States
  • Footnotes
    Commercial Relationships   Thomas Chalberg SightGlass Vision, Inc., Code C (Consultant/Contractor), Genascence Corp., Code E (Employment), SightGlass Vision, Inc.; Exhaura, Ltd.; Irenix Medical; Genascence Corp., Code O (Owner), SightGlass Vision, Inc.; Exhaura Ltd.; Irenix Medical; Genascence Corp., Code P (Patent); Deborah Laughton SightGlass Vision, Inc., Code E (Employment); Jennifer Hill SightGlass Vision, Inc., Code E (Employment); Vanessa Tasso SightGlass Vision, Inc., Code E (Employment); Graeme Young SightGlass Vision, Inc., Code C (Consultant/Contractor); Christopher Hunt SightGlass Vision, Inc., Code C (Consultant/Contractor); Jay Neitz SightGlass Vision, Inc., Code I (Personal Financial Interest), SightGlass Vision, Inc., Code P (Patent); Maureen Neitz SightGlass Vision, Inc., Code I (Personal Financial Interest), SightGlass Vision, Inc., Code P (Patent)
  • Footnotes
    Support  None
Investigative Ophthalmology & Visual Science June 2023, Vol.64, 5092. doi:
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      Thomas Chalberg, Deborah Laughton, Jennifer Hill, Vanessa Tasso, Graeme Young, Christopher Hunt, Jay Neitz, Maureen Neitz; Control of Myopia Using Diffusion Optics Spectacle Lenses: Efficacy and Safety Study (CYPRESS) 42-month results. Invest. Ophthalmol. Vis. Sci. 2023;64(8):5092.

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      © ARVO (1962-2015); The Authors (2016-present)

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Abstract

Purpose : The discovery that L/M opsin mutations are associated with familial high myopia led to the hypothesis that elevated contrast signalling in the retina, whether from genetic predisposition or the visual environment, plays an important role in myopia development and progression. To evaluate this theory, novel spectacle lenses (DOT lenses) were designed to modulate retinal contrast. CYPRESS evaluated the safety and efficacy of DOT lenses in reducing myopia progression.

Methods : CYPRESS part 1 (NCT03623074) was a 3-year double-masked, randomized, controlled clinical trial. Myopic children aged 6-10 years (n=256) were recruited at 14 clinical sites in North America and dispensed spectacles with one of two DOT lens designs (T1, T2) or standard single-vision control lenses. Children completing part 1 (n=200) were invited to enroll in CYPRESS part 2 (NCT04947735), in which T1 (n=35) and Control groups (n=42) continued with their original lens assignment and the T2 group (n=21) were crossed over to T1 lenses. Axial Length (AL) and cycloplegic Spherical Equivalent Refraction (SER) were measured at baseline, 12, 24, 36 and 42 months.

Results : In part 1 after 36 months, AL mean change ± SE from baseline was 0.59 ± 0.04 mm, 0.67 ± 0.05 mm and 0.72 ± 0.04 mm, and SER mean change from baseline was -0.83 ± 0.09 D, -1.19 ± 0.11 D and -1.16 ± 0.09 D, for T1, T2 and Control, respectively. Both co-primary endpoints of AL and SER were met, with a difference between means (T1 minus Control) of - 0.13 mm for AL (p=0.018) and 0.33 D for SER (p=0.008). Most of the benefit accrued within Year 1. During Years 2-3, which coincided with COVID-19, the children reported altered school routines, which likely impacted study outcomes.
In part 2, LS mean change ± SE from 36 to 42 months in AL was 0.08 ± 0.01 mm for T1 and 0.12 ± 0.01 mm for Control (p=0.013) and in SER was -0.12 ± 0.03 D for T1 and -0.21 ± 0.04 D for Control (p=0.051). Mean AL and SER progression in part 2 was not statistically different between the original T1 group and those who crossed over from T2 to T1 (AL p=0.28, SER p=0.85).

Conclusions : DOT spectacle lenses are safe and effective at reducing myopia progression in children age 6-10, with additional benefit evident after 3-years of wear. Changes in lifestyle, behaviour and schooling during the COVID-19 pandemic may have impacted treatment efficacy in Part 1.

This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.

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