Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes

Area of Science:

• Ophthalmology
• Biomedical Engineering
• Corneal Surgery

Background:

• Presbyopia, an age-related condition, reduces the eye's ability to focus on near objects.
• Current treatments for presbyopia include reading glasses, multifocal contact lenses, and refractive surgery.
• The Raindrop Near Vision Inlay represents a novel approach to presbyopia correction using a shape-changing corneal implant.

Purpose of the Study:

• To evaluate the 1-year safety and efficacy of the Raindrop Near Vision Inlay for treating presbyopia.
• To assess visual acuity, refractive stability, contrast sensitivity, and patient-reported outcomes.
• To document adverse events associated with the corneal inlay implantation.

Main Methods:

• A prospective, nonrandomized, multicenter clinical trial was conducted under an FDA Investigational Device Exemption.
• The Raindrop Near Vision Inlay was implanted in the non-dominant eyes of 373 emmetropic presbyopic subjects.
• Outcomes measured included uncorrected and corrected visual acuity, contrast sensitivity, and patient questionnaires at 1-year follow-up.

Main Results:

• Significant improvements in uncorrected near visual acuity (UNVA) by 5.1 lines and uncorrected intermediate visual acuity (UIVA) by 2.5 lines were observed at 1 year.
• Binocular uncorrected distance visual acuity (UDVA) remained stable and exceeded 20/20 throughout the study period.
• High patient satisfaction was reported, with minimal visual or ocular symptoms and treatable adverse events.

Conclusions:

• The Raindrop Near Vision Inlay effectively enhances near and intermediate vision in presbyopic patients.
• The inlay demonstrates a favorable safety profile with no significant impact on binocular distance vision or contrast sensitivity.
• The device leads to significant improvements in patient satisfaction with minimal reported symptoms.