Recent research published in Optometry and Vision Science details 7-year clinical data on the post-treatment impact of CooperVision’s MiSight 1 day dual-focus soft contact lenses for myopia control.
First up: these lenses.
MiSight was FDA-approved in 2019 as the first and only soft contact lens for slowing myopia progression among pediatric patients.
- Note: This is based on 2019 clinical research.
About its indication: With an omafilcon A soft (hydrophilic) lens and a unique optical design (dual-focus), the MiSight 1 day is indicated for daily wear to correct myopic ametropia and slow myopia progression among pediatric patients with non-diseased eyes.
- Specifically: These pediatric patients must:
- Be age 8-12 at the start of treatment
- Have a refraction of -0.75 to -4.00 diopters (D; spherical equivalent) with ≤ 0.75 D of astigmatism
Any special technology included?
That would be ActivControl Technology, a specialty contact lens technology for pediatric patients that both corrects vision and slows myopia progression for “age appropriate” (that 8-12 age range) children.
What it does: ActivControl is specifically designed to reduce myopia progression by controlling axial length and refractive error—potentially helping to "reduce the risk of myopia-related vision complications” later in life.
Alrighty, now to the basis for this clinical research.
The clinical study was composed of pediatric patients who completed a 2022 clinical study that reported 6-year data on the MiSight 1 day—notably, a follow-up to the 2019 3-year trial that supported the lenses’ FDA approval.
- See here for outcomes from the 3-year study and click here for the 6-year study outcomes.
And the 7-year study details?
- The study design: bilateral, open-label clinical trial
- The participants: 78 myopic pediatric patients who completed the aforementioned 6-year and 3-year parts of the MiSight 1 clinical studies from 2022 and 2019, respectively
- Notably: These patients continued into a follow-on 1-year “wash-out” phase to be fit with single-vision (Proclear 1 day; CooperVision) lenses
- The setup: Data from the right and left eyes were analyzed from:
- Patients with 6 years of treatment during the previous study (T3; n = 38)
- Patients receiving single-vision treatment during year 4 and 6 of previous study (T6; n = 40)
As for the primary outcome measures: Cycloplegic SERs and axial length (AL), measured every 12 months for 7 years.
- Important to note: Investigators estimated the expected axial growth and myopia progression from years 4 to 7 if treatment had not been started by using population-based estimates of age effects on growth rates to extrapolate growth of untreated myopic control eyes collected during years 1 to 3.
And what were the findings?
At the conclusion of this study, 76 patients (39 in the T3 and 37 in the T6 groups) completed their last visit.
As such, data on these primary outcome measures were as follows during the untreated year 7:
- Annualized axial growth: 0.09 ± 0.09 mm/y in the T3 group versus 0.10 ± 0.10 mm/y in the T6 group
- Compared to the previous year of treatment: 0.07 ± 0.12 (T3 group) vs. 0.08 ± 0.07 mm (T6 group)
- Annualized refractive changes: −0.23 ± 0.36 D/y in the T3 group versus −0.21 ± 0.40 D/y in the T6 group
- Compared to the previous year of treatment: −0.04 ± 0.34 (T3 group) vs. −0.13 ± 0.42 D
And how did year 7 myopic progression vary by age group?
Investigators noted that this progression was less for older patients (age 11 to 12) compared to the younger patient subgroup (age 8 to 10) at baseline.
- Older patients: −0.17 ± 0.40 D/0.05 ± 0.07 mm
- Younger patients: −0.26 ± 0.36 D/0.13 ± 0.10 mm
An important finding: Post-treatment growth or myopic progression was not influenced by the number of years a patient was in treatment.
Now to that expected slowing of axial growth and myopia progression.
Starting with axial growth: An assumed 15% growth slowing model was used.
The predicted average growth during year 7 was 0.08 mm (standard deviation [SD]: 0.05 mm); comparatively, the actual average growth rates for both treatment groups were:
- 0.09 mm (T3 group)
- 0.10 mm (T6 group)
Note: These rates were markedly greater by an estimated 0.01 mm from the expected growth if left untreated (p = 0.39 and p = 0.16, respectively)
- And see here for how age influenced the projected and actual axial growth outcomes.
And the projected myopic progression?
The model: An estimated 10% slowing per year if left untreated.
The projected myopia progression during year 7 was -0.17 D—while the actual slowing of progression was:
- –0.23 D (T3 group)
- –0.21 D (T6 group)
Notably: Neither of these differences (p = 0.16 and p = 0.37, respectively) was significant or clinically meaningful.
Any adverse events observed?
Just four ocular-based adverse events in five patients.
- Bacterial conjunctivitis (four cases)
- Corneal staining (three related cases)
Importantly: These were deemed to be nonsignificant, mild, and resolved quickly—as well as “similar to those observed in earlier phases of the study.”
And the conclusions based on this?
Investigators reported that, following the removal of the MiSight 1 day lens, patients’ myopic progression was returned “to age-expected untreated myopia progression and eye growth, irrespective of treatment duration (3 or 6 years) or of age at cessation.”
Additionally: The study authors wrote there was no evidence to support that prior treatment gains achieved with MiSight 1 day lens wear are lost once a patient stops wearing them.
Instead: “Accrued treatment benefits are retained if treatment is ceased during the teenage years,” they stated.