Study of Safety and Efficacy of Refractive Corneal Inlay in Patients With Cataract Surgery: Preliminary Results
Narrative Responses:
Purpose
The purpose of this study is to evaluate the safety and efficacy of the refractive corneal inlay Flexivue™ Micro-Lens for restoring near vision in patients with cataract surgery.
Methods
The Flexivue™Micro-Lens is a transparent, hydrophilic disc.The central 1.6 mm diameter of the disc is plano and the peripheral zone has an add power.The lens is placed in the center of the cornea of non-dominant eye corresponding to the visual axes in a corneal pocket created by femtosecond laser.Patients are randomly assigned to one of three groups:Group I–Three months after tunnel creation bilateral cataract surgery is performed.Three months afterwards, the inlay is inserted into the tunnel.Group II–Three days after tunnel creation and inlay insertion, bilateral cataract surgery is performed.Group III–Three months after bilateral cataract surgery, tunnel is created and inlay inserted.
Results
First results of ten patients (4 in group I, 3 in group II and 3 in group III) show that mean bilateral uncorrected distance visual acuity increased from 20/50 to 20/25 and mean bilateral uncorrected near visual acuity increased from 20/80 to 20/25. No intra/postoperative complications were found.
Conclusion
Refractive corneal inlays seem to be safe and effective method for restoring near vision in patients having cataract surgery.