A recently published study demonstrates significant benefits of wavefront-guided scleral lenses (wfgSL) in patients’ with irregular corneal astigmatism. This  prospective, randomized, double-blind, crossover study was conducted at the Cornea and Laser Eye Institute (CLEI), led by Dr. John Gelles. This study utilizes the OVITZ xwave aberrometer to compare objective and subjective results between wfgSL with traditional scleral lenses (tSL) in a clinical population.  The results revealed three major findings: a significant reduction in residual aberrations, improved visual acuity, and overwhelmingly positive patient response. This clinical study provides insight to both eye care practitioners and patients looking to enhance their vision.

This is the most comprehensive clinical study to date in this area. This study was designed to reflect real-world clinical conditions, unlike many prior trials with restrictive patient selection criteria. Participants in this study were dispensed a wfgSL and tSL in a double-blind, randomized order and expected to compare the visual performance of each set of lenses for several weeks. This time period would allow patients to fully test the lenses in various aspects of their daily activities. The investigators collected both optical metrics and patient self-reported outcomes. The brief summary below highlights the study and its key results. See the complete study here.

In the study, titled Visual Improvement With Wavefront-Guided Scleral Lenses for Irregular Corneal Astigmatism, Clinicians first finalized a tSL fit with standard spherocyl optics. Once this foundational fit was established, residual ocular aberrations were performed over this lens  under scotopic conditions, without pharmacologic dilation, using a Hartmann-Shack sensor. The non-dilated dim lighting conditions would simulate real-world viewing environments where such aberrations can be most impactful.

A freeform, wavefront-guided optical profile was designed and applied to the anterior optical surface of a commercially available scleral lens platform (ARES Scleral Lens by Valley Contax). Lens position, rotation, and tilt were accounted for so that the bespoke optics aligned over the subject’s visual axis during wear.

Each participant wore both lens types in a double-blind, randomized order for 4±1 week interval each before returning for assessment. At each visit, higher-order RMS, visual acuity, and patient’s subjective lens preference were recorded.

At the final visit, subjects were asked about their subjective lens preference between wfgSL and tSL. An overwhelming majority of the clinical group expressed a preference for the wavefront-guided lens after experiencing both lens options.

Seventeen of 18 patients subjectively preferred the wavefront-guided scleral lens (wfgSL), and one preferred the traditional scleral lens (tSL). That’s 94% wfgSL vs 6% tSL by patient-reported preference.

This subjective preference towards wfgSL correlates with many patients’ desire to seek specialty care due to the negative impact of  night glare, halos, ghosting, and low-contrast fatigue. For many practitioners this is practical and valuable data to share with patients seeking vision enhancement.

Aberrometry data was pupil matched and normalized to allow proper comparison of the data. At a fixed 5 mm pupil, the total higher-order RMS decreased by roughly half (56% (P<0.001)) with the wavefront-guided design compared to the traditional sclera. Reduction of residual HOAs of each eye with the wfgSL ranged from modest (18%) to substantial (83%). Results at a 3 mm pupil followed the same pattern, indicating that the effect is not confined to a single pupil diameter.

The study also stratified the subject data into subgroups based on corneal condition. The residual HOAs for each were consistently reduced among all three subgroups:

• Keratoconus eyes averaged HORMS reduction of 58% at 5mm pupil (P<0.001) and notable reduction in coma values and spherical aberration.
• Post-refractive ectasia eyes averaged  HORMS reduction of 54% at 5mm pupil (P<0.001) and notable reduction in coma values and secondary astigmatism.

Post-PK eyes experienced a more modest reduction of HORMS (41% at 5mm pupil (P=0.12)) due to limitations from  scarring and/or media issues.

The wavefront-guided lens resulted in improved visual acuity for the majority of eyes, with 71% gaining at least one line .A smaller fraction (26%) remained unchanged, and only a few (3%) lost a line. The observed improvement in vision is significant, even though not all subjects gained an additional line of visual acuity. This finding, combined with a greater reduction in residual aberration and the noted patient preference, suggests an enhanced quality of vision despite a lack of quantifiable improvement in visual acuity lines.

A traditional scleral lens improves vision by creating a smooth anterior refracting surface. It does not neutralize internal or posterior sources of aberration that can continue to degrade the retinal image.

Measuring the total ocular aberrations over a stabilized tSL captures residual aberrations that remain even after the liquid reservoir and front surface have done their part.

The total ocular aberrations are analyzed and identified into individual Zernike coefficients. These values are used to create a freeform optical pattern designed to negate the subject’s individually measured aberrations. With a platform that measures aberrations and produces wavefront guided optics, patients can benefit from a lens that targets the aberrations they actually experience. This is why many report cleaner headlights, fewer halos, less ghosting, and more comfortable low-contrast performance, even when baseline acuity appeared acceptable on paper.

Although all three subgroups showed reductions in residual HORMS with the wavefront-guided design, there were additionally notable patterns

• Keratoconus eyes demonstrated consistent HORMS reduction with frequent acuity gains.
• Post-Ectasia eyes showed meaningful reductions in coma-like terms along with strong subject preference toward the wfgSL
• Post-PK eyes demonstrated subjective and objective improvement even with limitations in overall visual acuity from scarring and media quality..

This clinical study established real-world application of HOA correction in a high-volume specialty eye care practice by utilizing commercially available diagnostic equipment and contact lenses and deliberately avoiding pharmacological dilation. This methodology reflects a workflow that busy specialty clinics can implement.

The outcomes address exactly why many patients seek second opinions after a “good” refraction: the desire to achieve comfortable vision by reducing persistent night glare, halos, ghosting, and low-contrast fatigue.

Limitations of this report reflect an interim analysis with small sample size in some subgroups. Future research with larger samples is needed to confirm effect sizes and population characteristics. Areas of interest for further investigation include: stability over longer follow-up, the impact of media opacities, and near-to-intermediate performance in presbyopes.

However, none of these considerations change the central conclusions: In a controlled, randomized comparison that used real-world tools, wavefront-guided scleral lenses reduced residual HOAs, improved acuity for most eyes, and were greatly preferred by most participants.

For clinics comfortable with scleral fitting and basic HOA concepts, this study — the most comprehensive clinical study ever of its type — validates the transition from traditional optics to wavefront-guided optics. The protocol measures what remains after establishing a strong traditional fit, then building a correction that addresses residual visual disturbances. The findings support adoption of wfgSL for irregular cornea populations where quality-of-vision complaints persist despite acceptable acuity.

Eye care professionals who want to ask technical questions or explore training can contact OVITZ to learn more or to become an OVITZ-Authorized Doctor. We will help evaluate candidacy, workflow, and integration based on your patient mix.