First Author: C.Baily IRELAND
Co Author(s): M. O'Keefe
Purpose:
To clinically evaluate the effect of the ICOLENS corneal inlay (ICI) in the treatment of presbyopia.
Setting:
Prospective clinical trial carried out in the Mater Private Hospital, Dublin, Ireland.
Methods:
A prospective non-randomised clinical study. Inclusion criteria included emmetropia (spherical equivalent :-0.25 to +1.00), unambiguous ocular dominance, pupil diameter between 2.4 to 4.2 mm at photopic illumination, central corneal thickness >500µm and uncorrected near visual acuity(UNVA) of 0.4logMAR(20/50) in the non-dominant eye. The ICI (3mm diameter, 20µm thickness) was inserted into the non-dominant eye. The optical principle utilised is that of a bifocal lens with a central zone for distance visual acuity (VA) and a peripheral optical zone for near VA. The procedure was performed under local anaesthesia and involved insertion of the lens into the corneal stroma by using a specific femtosecond pocket-cutting algorithm. The ICI has been inserted into 36 eyes to date. The recruitment process is ongoing with a estimated target of 45 patients. Outcome measurements included near and distance vision and adverse events.
Results:
There was a mean gain of 3.49 lines of logMAR monocular UNVA in the surgical eye. On vocational reading testing 100% were between N5 and N10, with 40% between N5 and N6. There was a mean±standard deviation (SD) loss of lines of -1.75±1.56 on monocular uncorrected distance visual acuity (UDVA) and a mean±SD gain of 0.33±1.12 on binocular UDVA. There was a mean follow up of 8 weeks (range 1-24). No adverse events were reported.
Conclusions:
This is a new corneal inlay for the treatment of presbyopia that demonstates a substantial improvement in UNVA with a moderate loss of monocular UDVA. FINANCIAL DISCLOSURE?: No
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