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06 March 2025

ICL V4c Outperforms FS-LASIK For Presbyopic Myopia Surgery

Long-term study indicates monovision procedures effectively improve visual acuity and satisfaction for aging patients

A recent study has disclosed valuable insights on monovision surgery, comparing outcomes derived from two distinct surgical approaches—implantable collamer lens (ICL V4c) and femtosecond laser-assisted LASIK (FS-LASIK)—targeting myopic patients grappling with early presbyopia. Conducted at the Eye and Ear, Nose, Throat Hospital of Fudan University, Shanghai, China, this research involved 48 eyes from 24 participants (10 males and 14 females), with the mean age of approximately 45.5 years. The follow-up duration extended to around 4.5 years.

Presbyopia, characterized by the gradual loss of the eye's ability to focus on nearby objects, is becoming increasingly prevalent, currently affecting approximately 2.1 billion individuals globally. The rise of myopia is equally alarming, projected to reach 4.758 billion people by 2050, inclusive of 938 million anticipated to suffer from high myopia. This stark reality calls for effective treatment avenues, particularly for patients aged over 40.

The study embarked on evaluating the safety and efficacy indices of the ICL V4c and FS-LASIK techniques. The findings highlighted the safety indices at 1.17 ± 0.30 for the ICL V4c group, contrasting with the FS-LASIK group’s 0.98 ± 0.20, establishing statistical significance (p < 0.05). Meanwhile, efficacy indices stood at 0.79 ± 0.07 for the ICL V4c group. The authors stated, "Monovision surgery using ICL V4c or FS-LASIK provides good binocular visual acuity at near-to-far distances..."

Utilized to correct distance vision for the dominant eye and near vision for the non-dominant eye, monovision has garnered attention as an effective solution for managing myopia patients faced with presbyopia. Various methods are employed for this treatment, encompassing frame spectacles, contact lenses, corneal inlays, lens replacements, and currently, refractive surgical techniques like ICL implantation and FS-LASIK.

Each surgery was executed without complications, and both techniques yielded significant improvements. For the binocular visual acuity (VA) at varying distances, the ICL V4c group reported logMAR values such as 0.02 ± 0.11 at 5.0 m, which significantly outperformed the FS-LASIK group's 0.18 ± 0.30. At distances of 0.8 m and 0.4 m, the ICL V4c group similarly prevailed, demonstrating similar logMAR values, which reinforces its effectiveness as compared to FS-LASIK.

Notably, the study also observed distinctions concerning patient-reported satisfaction over follow-ups. At the last analysis, 66.67% of participants receiving ICL V4c perceived their visual acuity at near distances as satisfactory. Satisfaction rates for near vision were 33.3%, 91.67%, and 66.67% pre-operatively, 3 months postoperatively, and at the final visit, respectively. Conversely, the FS-LASIK group exhibited satisfaction levels decreasing from 33.3% preoperatively to 50.0% at the concluding follow-up.

Contrastingly, lower levels of visual acuity and satisfaction were observed where the FS-LASIK procedure featured reduced efficacy, with the reported mean of the efficacy index coming to 0.52 ± 0.07 as compared to the ICL V4c's 0.79 ± 0.07—both denoting statistically significant differences (p < 0.05). The findings prompt discussions pertaining to the choice of procedure depending on specific patient needs and expectations, particularly concerning near and far vision demands.

The study also reported on the safety indices, with no cataract or retinal detachment ensuing as per the follow-up results for both surgical approaches. Trends revealed the spherical equivalent values closely approximated those anticipated post-treatment—66.67% of the ICL V4c and 58.33% of the FS-LASIK patients demonstrated spherical residual error within ± 0.5 D of the expected value.

This comparative analysis sheds light on the options available for corrective measures to manage myopia among patients nearing presbyopia, affirming the position of monovision surgery as practical and effective. By demonstrating the comparative advantages of ICL V4c over FS-LASIK, healthcare professionals can make informed recommendations based on patient circumstances, offering the potential for enhanced visual outcomes and increased patient satisfaction.

Future research is warranted to expand this patient analysis, exploring the revisions and variations based on differing myopia levels and treatment methodologies to deepen comprehension of long-term effects. This research signifies compelling advancements aimed at amelioration of visual deficits associated with aging populations—particularly those experiencing presbyopia alongside myopic conditions.