ABSTRACT
PURPOSE: To evaluate the effectiveness and safety of a new presbyopia-correcting intraocular lens (IOL) with a nondiffractive design, DFT015, compared with an aspheric monofocal IOL, SN60WF. SETTING: 19 investigational sites in 4 countries: Australia, Canada, Spain, and the United Kingdom. DESIGN: Prospective, randomized, parallel-group, controlled, assessor- and patient-masked clinical study. METHODS: Participants aged ≥22 years with bilateral cataracts were randomized to DFT015 or SN60WF in a 5:4 ratio and masked until final postoperative follow-up at month 6. The primary effectiveness objective was superiority of DFT015 over SN60WF in mean monocular photopic distance-corrected intermediate visual acuity (DCIVA) at month 3. Secondary effectiveness objectives included noninferiority of DFT015 to SN60WF in mean monocular photopic corrected distance visual acuity (CDVA) and superiority in the mean monocular photopic distance-corrected near visual acuity (DCNVA) at month 3. Visual disturbances were assessed at month 6. RESULTS: 282 patients were randomized to DFT015 (n = 159) or SN60WF (n = 123). All effectiveness objectives were achieved at month 3 in first eyes. For monocular photopic results in first eyes, DFT015 demonstrated superior mean DCIVA (least squares means of -0.139 logMAR in favor of DFT015, P < .001), noninferior mean CDVA (97.5% upper confidence limit [UCL] of the difference was <0.1 logMAR) and superior mean DCNVA (95% UCL of the difference was <0.0 logMAR) compared with SN60WF at month 6. DFT015 exhibited a similar visual disturbance profile to that of SN60WF. CONCLUSIONS: DFT015 provided superior intermediate and near vision and a similar visual disturbance profile compared with an aspheric monofocal IOL.
Subject(s)
Lenses, Intraocular , Phacoemulsification , Presbyopia , Humans , Lens Implantation, Intraocular , Presbyopia/surgery , Prospective Studies , Prosthesis DesignABSTRACT
PURPOSE: To evaluate the safety and efficacy of a new multi-segmented refractive multifocal intraocular lens (IOL) after phacoemulsification and refractive lens exchange (RLE). PATIENTS AND METHODS: In this prospective, multicenter clinical trial, 63 presbyopic subjects who had cataract or where RLE candidates were bilaterally implanted with the Precizon Presbyopia IOL (Ophtec BV, Groningen, the Netherlands) after phacoemulsification. The study was conducted at 6 clinical centers in Germany, the Netherlands, Belgium, Turkey and Spain. Subjects were evaluated at baseline and at 1 day, 1 week, 1 and 3 months postoperatively for monocular and binocular uncorrected (UDVA) and corrected distance visual acuity (CDVA), uncorrected (UIVA) and distance-corrected intermediate visual acuity (DCIVA), uncorrected (UNVA), corrected (CNVA) and distance-corrected near visual acuity (DCNVA), contrast sensitivity and quality of vision. RESULTS: Three months postoperatively, binocular UDVA and CDVA of ≥20/40 was achieved in 98.4% (60/61) and 100%, respectively. Binocular UIVA and DCIVA of ≥20/40 was achieved in 96.7% (59/61) and 93.4% (57/61) respectively. Binocular UNVA, CNVA and DCNVA of ≥20/40 was achieved in 93.4% (57/61), 98.4% (60/61) and 95% (57/60) subjects, respectively. Complete spectacle independence was achieved in 80% (49/61) patients; 93% of patients reported that they were quite or very satisfied with the outcomes of the procedure. CONCLUSION: Precizon Presbyopia IOL implantation is a safe and effective method to provide good visual acuity at all distances in presbyopic and cataract patients.
ABSTRACT
Presbyopia is a condition that affects many as the lens ages, and is a secondary effect of cataract surgery. Multifocal lenses for the treatment of presbyopia have been undergoing cycles of development and improvement over the past two decades. The latest advancements have yielded lenses with a continuous range of optical powers, otherwise known as continuous transitional focus (CTF) lenses. Modern CTF lenses provide a more natural experience for patients while minimizing unwanted optical side effects.
