Safety And Efficacy Of Biosynthetic Collagen Corneal Presbyopic Microlens

To assess the safety and effectiveness of implantation of presbyopic corneal inlay made from medical-grade type I biosynthetic collagen.

Gemini Eye Clinic, Zlin, the Czech Republic

The study includes 110 patients aged 40-65 years with near addition +1.25 D to +3.50 D. Patients with spherical equivalent (SE) -0.75 D to +1.50 D and ≤1.5 D cyl in the non-dominant eye were included while patients with corneal thickness <470 µm and corneal curvature ≥ 50 D or significant eye pathology were excluded. The corneal microlens (CorVision, LinkoCare, Sweden) was implanted into a 6 mm pocket at depth of 140–220 µm created by a femtosecond laser in the non-dominant eye only. Uncorrected and corrected visual acuities at 40cm near (UNVA, DCNVA), 66cm intermediate (UIVA, DCIVA) and 4m distances (UDVA, CDVA), refraction, corneal topography, intraocular pressure (IOP) and slit lamp examination were recorded up to 1 year.

Interim results after 6 months for 107 eyes show that UNVA at 40 cm improved from 0.60±0.15 logMAR to 0.17±0.13 logMAR. UDVA worsen from 0.07±0.13 logMAR to 0.35±0.23 logMAR while CDVA remained stable, preop -0.03±0.07 logMAR, postop 0.01±0.11 logMAR. Manifest refraction SE changed from preop 0.33±0.40 D to -1.39±0.69 D. Binocular UNVA improved from 0.46±0.15 to 0.15±0.13 and binocular UDVA remained unchanged (-0.11±0.09 logMAR preoperative and -0.12±0.07 logMAR). There were nine eyes with a temporary IOP increase (steroid respondents), four patients complains of visual disturbances, two dry eyes and two mild cornea hazes. AE were temporally and mostly ceased. Two patients did not adapt to monovision and had the microlens explanted.

The presbyopic corneal biosynthetic collagen microlens appears safe and effective in correction of presbyopia. Binocular UNVA significantly improved while binocular UDVA remained unchanged.