Extended depth of focus contact lens: an efficacy pilot study

Paper title: Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens

Authors: Cooper, Jeffrey (1); O’Connor, Brett (2); Watanabe, Ronald (3); Fuerst, Randall (4); Berger, Sharon (5); Eisenberg, Nadine (6); Dillehay, Sally M (7)

1. State University of New York College of Optometry, New York, NY
2. Pullen Eye Care, Jacksonville, FL
3. New England College of Optometry, Boston, MA
4. EYECenter Optometric, Orangevale, CA
5. Roswell Eye Clinic, Roswell, GA
6. Cooper Eye Care (N.E.), New York, NY
7. Visioneering technologies, Inc., Alpharetta, GA

Date: Sep 2018

Reference: Cooper J, O’Connor B, Watanabe R, Fuerst R, Berger S, Eisenberg N, Dillehay SM. Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens. Eye Contact Lens. 2018 Sep;44(5): e16-e2

[Link to abstract]

Spherical spectacles and contact lenses are thought to give a clear image on the central retina but relative hyperopic defocus in the peripheral retina.  The peripheral blur is thought to induce axial length growth in an attempt to receive a clearer image in this area.

 NaturalVue from Visioneering Technologies is designed to be a centre-distance multifocal with a high amount of relative plus power in the periphery of the optic zone.  This is expected to give the wearer an extended depth of focus and reduce the hyperopic peripheral focus on the peripheral retina.

Cooper et al retrospectively analysed the myopic progression of 32 children after they were fitted with NaturalVue.  They had all shown previous myopic progression with their current spectacles or contact lenses.  Their progression was assessed at various follow-up intervals to compare the rate of their individual progression before and after being fitted with NaturalVue.

The aim of the study was to discover the rate of myopic progression in children fitted with this lens in clinical practice settings.  The majority of the children were found to have experienced less myopic progression than would be expected annually and a small percentage appeared to demonstrate myopic regression.

This conclusion is that NaturalVue is a viable option for myopia control where it has shown to reduce the refractive error and myopic progression.  The authors suggest that the extended depth of focus and the high peripheral plus power the lens design offers are the driving force in slowing the progression.      

In this small retrospective study, the authors focused on individual children's myopia progression, highlighting real-life scenarios. All participants showed at least -0.50D progression before using NaturalVue, including those with prior orthokeratology or different soft multifocal lenses. While the effectiveness of these options remains unclear, finding alternatives promptly is crucial during progression.

Results indicated that 1.56% exhibited increased myopia with NaturalVue. The study emphasized the need for personalized approaches, as not every option suits every child. Early intervention, as seen in an 8-year-old boy, can effectively control myopia progression, particularly in age groups prone to eye growth.

The study used refractive error change as a success measure since not all practitioners have axial length measurement tools. Monitoring refractive change at follow-up visits revealed 84.38% of children demonstrating substantial myopic progression rate improvement. NaturalVue Myopia Control has a place among available options, recognizing the variability in intervention effectiveness. 

This preliminary data collection using case series analysis preceding a randomized clinical trial acknowledges several limitations:

• Retrospective Nature: The study lacks predictability for the longevity of NaturalVue results, with no predictive element for participants still wearing the lens post-study.
• Non-Random Selection: Participants were intentionally selected based on dissatisfaction with their previous correction, showing at least -0.50D progression, making it hard to generalize the results.
• Small Sample Size: With only 32 participants, caution is needed when extrapolating the findings to a broader population.
• Lack of Control Group: The absence of a control group limits the ability to compare the efficacy of NaturalVue directly to other interventions.
• Methodological Issues: No standardized refraction technique, cycloplegic refraction, or axial length data raises concerns about result consistency and interpretation.
• Limited Study Duration: The short study duration and varied wear times for NaturalVue (6 to 25 months) may not fully capture its long-term effectiveness.
• Need for Larger Study: A prospective, randomized study with a control group is essential to address these limitations and provide more robust insights into NaturalVue's effectiveness in combination therapy and across different stages of myopia management.

Further research could tell us how effective NaturalVue might be as part of a combination therapy as well as providing data on a larger number of participants with more children at different stages of their myopia management ‘journey’ and if refractive changes coincide with changes in axial length. 

Title:  Case Series Analysis of Myopic Progression Control With a Unique Extended Depth of Focus Multifocal Contact Lens

Authors: Cooper, Jeffrey; O’Connor, Brett; Watanabe, Ronald; Fuerst, Randall; Berger, Sharon; Eisenberg, Nadine; Dillehay, Sally M

Purpose: To determine the rate of myopia progression in children fit with a commercially available extended depth of focus (center distance) multifocal soft contact lens with attributes theoretically expected to slow the progression of myopia.

Methods: A retrospective case series analysis of 32 patients (ages 6-19 years, mean 10.98±2.95) from 10 practice locations was performed. At initial presentation, 44% wore spectacles, 37.5% spherical soft contact lenses, 15.6% a different soft multifocal contact lens, and 3% orthokeratology lenses. All participants showed progression of at least -0.50 diopter with current corrections and were fit with an extended depth of focus (center distance) multifocal soft contact lens (NaturalVue Multifocal 1 Day Contact Lenses; Visioneering Technologies, Inc., Alpharetta, GA). Follow-up time was 6 to 25 months (mean: 10.94±4.76).

Results: Reductions in the annualized rate of myopic progression from -0.85 D per year ±0.43 D to -0.04 D per year ±0.18 D (P<0.00000) OD, -0.90 D per year ±0.57 D to -0.03 D per year ±0.17 D (P<0.00000) OS were observed. These data represent a reduction of 95.4% OD and 96.25% OS. Approximately 98.4% of the children showed reduction of annualized myopic progression; 91% showed a decrease of 70% or greater. Overall, 81.25% showed complete halting of myopic progression, including 6.25% demonstrating myopic regression.

Conclusions: This unique extended depth of focus (center distance) daily disposable multifocal contact lens was effective in slowing myopic progression in these children. These findings add to the growing evidence that center distance multifocal soft contact lenses may slow the progression of myopia.

[Link to abstract]