<p>A Novel Concept of Correcting Presbyopia: First Clinical Results with a Phakic Diffractive Intraocular Lens</p>

Abstract

Purpose: To evaluate the effect of a novel technique to correct presbyopia. A phakic IOL (presbyopic IPCL; implantable phakic contact lens) with a diffractive optic is implanted and its impact on visual acuity, refraction, patient satisfaction in patients striving for spectacleindependence is evaluated. Design: Retrospective noncomparative open-label clinical trial. Methods: Sixteen eyes of 8 patients (average age 47 years) had a presbyopic IPCL implanted in the posterior chamber. The visual acuity on different distances, refractive status, corneal topography, endothelial cell density, anterior chamber depth, white-to-white, mesopic pupil size and intraocular pressure (IOP) were measured before implantation of this novel phakic IOL with diffractive optic and four weeks after surgery. Results: At follow-up four weeks after surgery, 9 of the 16 eyes were emmetropic and uncorrected distance visual acuity was at least 0.8. Near vision was excellent in all patients without the need to wear reading glasses. There was neither a significant change in IOP nor a significant surgical impact on endothelial cells. Patient satisfaction was high. There was no major complaint of halos or glare. Conclusion: The presbyopic IPCL can provide the presbyopic patient with good visual acuity and spectacle-independence for far and near distance. We found this novel technique to have a good safety profile during the surgical procedure and our short follow-up period. Further long-term follow-up is mandatory.

Phakic intraocular lenses: an update and review for the treatment of myopia and myopic astigmatism in the United States

“…UDVA where emmetropia was the goal and preop best corrected VA was ≥20/20. Footnotes: Data based on FDA clinical trials [7 ▪▪ ,10–12]. ∗ 6 month FDA data and Kamiya et.…”

“…Subjective Patient Symptoms reported during FDA clinical trials. Footontes: Data based on FDA clinical trials [10–12], No subjective data was collected for EVO/EVO+ clinical trials, there was 1 report of EVO+ ICL removal from a patient with intolerable glare and halos.∗No data collected during Verisyse clinical trials on double vision or night vision issues.…”

“…Adverse Events Comparing Three FDA approved Phakic IOLs. Footnotes: Data based on FDA clinical trials [10–12] with exception to some EVO data from Kamiya et. al, 177 eyes with EVO ICL over 8 year follow up.…”

“…Artisan, and Visian ICLs do have plus sphere models used in the European market and elsewhere. Newer technology investigating presbyopic pIOLs (i.e., Veriflex presbyopic) is also on the horizon in the US but these trials have yet to begin their recruitment phase [11,12].…”

“…based on FDA clinical trials[10][11][12] with exception to some EVO data from Kamiya et. al, 177 eyes with EVO ICL over 8 year follow up * Of the 49 Verisyse patients with lens opacities only 4 (8.2%) were visually significant and 3 (6.1%) required extraction ¶ Visian ICL toric data was assumed to be similar to parent study with Visian ICL by the FDA ‡ Verisyse based off 12 month rates from FDA, except for ECL which was 3 years There were no reported cases of endophthalmitis in any lens type…”