Published in Research

Four-year data continues to support DOT spectacle lenses for myopia

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4 min read

SightGlass Vision, Inc., a joint venture of CooperCompanies and EssilorLuxottica, released positive 4-year data from the pivotal CYPRESS study extension evaluating the safety and efficacy of Diffusion Optics Technology (DOT 0.2) spectacle lenses for slowing pediatric myopia progression.

Let’s start with this technology.

SightGlass Vision’s proprietary, patent-protected DOT is a lens technology focused on possibly slowing axial elongation and control / reduce myopia progression.

The technology’s acronym lends to its ability to integrate thousands of light-scattering elements—”dots”—that imitate more natural contrast at all distances before hitting the retina, according to the company.

See below for a look at the DOT technology in use.

DOT technology

And these lenses?

Designed to be used with SightGlass Vision’s DOT, the spectacles are intended to reduce contrast signaling within the retina and potentially slow myopia progression—leading to clear central vision with slightly less contrast in the lens’s peripheral component.

Talk about this CYPRESS trial.

The original CYPRESS trial (NCT03623074) was a 3-year, double-masked, randomized, controlled study that enrolled 256 children (ages 6-10).

Participants were provided spectacles with one of two DOT lens designs (T1 or T2) or standard single-vision control lenses.

Now this extension.

Participants who completed CYPRESS (n = 42) were invited to enroll in the CYPRESS efficacy and safety study extension trial (NCT04947735), where T1 and control groups continued wearing their initial lenses, while T2 (n = 21) switched to T1 lenses.

A total of 98 participants were re-enrolled from the original 3-year study to generate an additional 6 months of new data.

Of note, axial length (AL) and cycloplegic spherical equivalent refraction (cSER) were measured at the following time points: baseline, 12, 24, 36, and 42 months.

And the results for these?

For CYPRESS, 36-month data found that both co-primary endpoints—AL and cSER—were met; a difference in means (T1 minus the control group) for AL was -0.13 (p = 0.018) and 0.33 D for cSER (p = 0.008)

Reported in April 2023, the extension study confirmed data from CYPRESS that the DOT spectacle lenses were effective and have a favorable safety profile in reducing myopia progression in pediatric patients (ages 6 - 10).

See here for our coverage.

Gotcha. Now talk about this new data.

Using data from the 98 participants who re-enrolled from the original CYPRESS study, the full 4-year results continued to demonstrate a statistically significant slowing for both AL and cSER.

Give me specifics.

From 36 to 48 months:

  • AL mean change
    • 0.13 ±0.02 mm for the DOT group (n = 55)
    • 0.18 ±0.02 mm for the control group (n = 41; p = 0.038)
  • cSER mean change
    • -0.25 ±0.04 D for the DOT group
    • -0.38 ±0.05 D for control (p = 0.043)

So what’s the big picture?

These latest results confirm that CYPRESS and the extension data support the favorable safety profile of DOT spectacle lenses for reducing pediatric myopia.

However, according to Clinical Trials, the extension study isn’t slated to conclude until June 2025 … so stay tuned for potentially an additional data readout!

*Featured image courtesy and property of SightGlass Vision, Inc.

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