Espansione Group Announces Topline Results from Refractive Surgery Study and Launch of Premium IOL Protocol Development

Espansione Group is pleased to announce the topline results of a recent study led by Dr. Sergio M. Solarino at Centro Vista, (Italy) in liaison with Prof. G. Giannaccare, Università di Cagliari (Italy) on the prevention of iatrogenic dry eye disease (DED) in patients undergoing refractive surgery. Concurrently, Espansione Group is launching the development of a premium IOL (Intraocular Lens) protocol currently under prospective clinical trial, following promising outcomes yielded in a senile cataract cohort with LM® LLLT (Light Modulation® Low-Level Light Therapy), conducted by Prof. Giuseppe Giannaccare in 2023 and published the same year on the British Journal of Ophthalmology.

Refractive Surgery: Prevalence, Incidence, and Challenges

Refractive surgery, including procedures like LASIK and PRK, is increasingly common, with an estimated market growth of USD 1.24 billion at a CAGR of 6.14% between 2023 and 2028. Despite the high demand, refractive surgeries are known to induce iatrogenic dry eye disease, a prevalent postoperative complication. Studies, including the TFOS DEWS II Iatrogenic Report, show that post-refractive surgery dry eye symptoms may persist for up to a year, affecting patient comfort and satisfaction.

Contact lens wearers are particularly at risk, with long-term use associated with reduced corneal sensitivity, which may exacerbate dry eye symptoms post-surgery. Both LASIK and SMILE procedures can cause significant transient corneal denervation, leading to prolonged recovery periods. Effective management of the ocular surface before and after surgery is crucial to minimize these complications and enhance patient outcomes.

Also, it is growing conviction amongst thought leaders in the field that stabilizing the tear film for symptomatic patients ahead of any surgery is of paramount importance for the procedure to yield its desired long-term results.

Study Overview and Results

The prospective, randomized clinical study was conducted at Centro Vista Clinic (Cagliari, Italy) in collaboration with the University of Cagliari (Italy). The study evaluated the effectiveness of LM® LLLT performed 1 week before and 2 weeks after corneal refractive surgery in preventing iatrogenic DED in otherwise healthy patients. The study assessed 24 eyes of 12 patients undergoing LASIK and PRK surgery. Parameters measured included Noninvasive Break-up Time (NIBUT), Tear Meniscus Height (TMH), Meibography scores, and Ocular Surface Disease Index (OSDI) questionnaires.

The key results collected 1 month postoperatively indicated that:

100% of patients had at least 1 altered parameter post-surgery, with the majority showing lower NIBUT vs. baseline
30% of patients exhibited alterations in all parameters
50% of patients had pathological TMH levels 2 weeks post-op
Patients receiving LM® LLLT treatment maintained better NIBUT, TMH and OSDI values compared to the control group, who experienced significant decline of all parameters.

These findings suggest that prophylactic use of LM® LLLT one week before and after refractive surgery can significantly improve tear film stability and reduce ocular discomfort, ultimately supporting faster recovery and better patient satisfaction with surgery.

Development of a Premium IOL Protocol

Building on the results of a randomized controlled trial led by Prof. Giuseppe Giannaccare, Espansione Group is advancing a new protocol leveraging LM® LLLT to elevate Premium IOL implants. The foundational study on senile cataract, which included 153 healthy patients, showed significant improvement in tear film stability and reduced ocular discomfort when LM® LLLT was applied one week before and after cataract surgery. These findings, published in the British Journal of Ophthalmology in 2023, highlighted the therapy’s potential in enhancing outcomes, motivating the integration of LM® LLLT with Premium IOLs procedures to improve patient’s tear film stability and surgical success, therefore elevating the procedure itself.

Note on MDR Approval

Dedicated Pre-/Post-surgery Protocols have been included in the recent MDR clearance for eye-light®, allowing any practitioner to safely run these protocols in their practice.

To read the full press release on the clearance, which opens new horizons in patient care from the front to the back of the eye (i.e., including the recently announced dAMD Protocol), please follow this link.

ABOUT ESPANSIONE GROUP

Espansione Group is an established player in the MedTech industry. Since 1981, Espansione Group has delivered the highest standard in the industry. Every day, the company invests heavily in researching and developing the Espansione Ecosystem to achieve its ambition: establishing new paradigms in ophthalmology and beyond, driven by its desire to provide its partners and their patients with the best, certified medical technologies, Light Modulation® Low-level Light Therapy (LM® LLLT) and Optimal Power Energy® Intense Pulsed Light (OPE® IPL). Present in over 50 countries, Espansione Group aims to continue its strong growth in years to come, relentlessly focusing its efforts on research, development, and customer excellence.    

For more information, see www.espansionegroup.it

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