Recent clinical findings on SightGlass Vision’s Diffusion Optics Technology (DOT) spectacle lenses demonstrated a high efficacy in managing myopia among pediatric patients.
The data were presented during the 2025 Association for Research and Vision in Ophthalmology (ARVO) earlier this month.
Before we get to this data, refresh me on DOT.
The company’s proprietary and patent-protected lens technology is designed to slow axial elongation—potentially resulting in the stabilization or reduction of myopia progression.
Connecting the “dots”: This tech integrates thousands of light-scattering elements that imitate more natural contrast at all distances before hitting the retina.
- In other words: The technology manages contrast to manage myopia.
And importantly: DOT is embedded in spectacle lenses exclusively designed for use with the technology.
Talk about those spectacle lenses.
The spectacles are intended to potentially slow myopia progression in pediatric patients—as young as 6 and up to age 13—via the DOT technology in its lenses.
How: As a complete package (spectacles and DIMS), the lenses reduce contrast signaling within the retina by softly scattering thousands of micro-dots of light and moderating it:
- Before hitting the retina
- Before the retina detects artificial contrast and signals the eye to elongate
The resulting effect: Clear central vision with slightly less contrast in the lens’s peripheral component.
What is its regulatory status in the U.S.?
Still investigational. In fact, the FDA granted Breakthrough Device designation to the DOT spectacle lenses in February 2024.
- The intent behind this: To expedite the clinical development and review process for SightGlass Vision’s spectacle lens and technology to treat or diagnose pediatric myopia.
Outside the United States: The spectacle lenses are already commercially available in the Chinese, Dutch, and Israeli ophthalmic markets (and are undergoing preliminary market trials elsewhere in the world).
And the clinical data on them?
Prior to this new ARVO research, real-world efficacy data came from the Control of Myopia using Peripheral Diffusion Lenses: Efficacy and Safety Study (CYPRESS) trial (NCT03623074), a 3-year study that has evaluated the DOT lenses for pediatric myopia.
- The data: Spectacle lens wear led to a decrease in myopia progression (later supported by findings from a later 4-year extension study).
- Some numbers:
- 65% of pediatric participants had no clinically meaningful myopia progression after 1 year
- 59% reduced myopia progression was reported after 2 years of full-time wear
- Some numbers:
Alrighty, now to this latest research.
The CATHAY study (NCT05562622) was conducted following the positive findings from the North American-based CYPRESS study.
Its purpose: evaluating the safety and efficacy of the DOT lenses in a Chinese pediatric population with an even greater prevalence and severity of myopia.
And the study details?
- The design: Randomized, controlled, evaluator-blinded, multicenter, two-arm parallel group trial
- The participants: 195 patients (aged 6 to 13) diagnosed with juvenile (pediatric) myopia
- The setup: Participants randomized 2:1 to wear either:
- DOT spectacle lenses
- Single-vision spectacle lenses
- Duration: 12 months
- Outcome measures (at 12 months):
- Axial length (AL), as determined by the change in AL from baseline
- Cycloplegic spherical equivalent refraction (cSER)
Now to the findings.
Out of the original 195, 186 participants (128 [69%] wearing DOT lenses; 58 [31%] wearing control lenses) completed the 12-month interim analysis visit.
And the outcome measures?
We’ll start with baseline averages (±SD):
- AL: 24.45 mm (0.80)
- cSER: –2.27 D (0.85)
What was the 12-month data?
For DOT lens wearers, there were no significant mean changes from baseline:
- AL: 0.09 ± 0.10 mm (95% Confidence Interval [CI]: -0.10 to 0.29, p=0.34)
- cSER: –0.17 ± 0.11D (95%CI: –0.38 to 0.05, p=0.13)
How about for the control lens wearers?
Unlike the DOT lens wearers, the 12-month mean changes were significant.
- AL: 0.35 ± 0.16 mm (95%CI: -0.66 to -0.04, p=0.03)
- cSER: -0.64 ± 0.16D (95%CI: -0.96 to -0.32, p=0.0001)
And between the two lens groups?
There was a significant difference (0.26 mm, p < 0.0001) in AL progression when comparing DOT lens versus control—equating to a 74% reduction.
Similarly, a significant difference ( –0.48 D, p < 0.001) in cSER progression was also observed for DOT lens versus control lens groups—translating to a 75% reduction.
So what’s the takeaway from this?
Essentially, reinforcement of the DOT lenses’ safety and effectiveness in reducing myopia progression among a diverse population of pediatric patients (this time in Chinese patients).
And take note: The CATHAY study is expected to continue through to the 24-month mark—so future findings are anticipated.
Nice! And are there any other new findings on the North American front?
Actually … yes. Also presented during ARVO, investigators revealed data from a trial that evaluated a subset (n = 49; mean age of 13.5 [10.8 to 15.5] years) of pediatric patients (from both the control and DOT lens groups) from the CYPRESS trial who underwent evaluations for an additional 12 months.
The difference with this evaluation: Patients who had worn the DOT spectacle lenses were crossed over to wear the control single-vision lens.
- The purpose: To determine (if any) rebound effects following discontinued wear of the DOT lenses.
And what did they find?
Interestingly, following 1 year of discontinued wear: “cSER and AL progression among this test group reverted to age-normative rates observed in the control.”The indication: There were no statistically or clinically significant rebound effects observed among these patients.