Dataset Information

Bilateral Implantation of a New Refractive Multi-Segmented Multifocal Intraocular Lens in Cataract or Refractive Lens Exchange Patients.

ABSTRACT:

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.

SUBMITTER: Holzer MP

PROVIDER: S-EPMC8149325 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:PurposeTo determine the cost effectiveness of an adjunctive screening OCT during the preoperative evaluation of a patient considering cataract surgery with a multifocal intraocular lens (IOL) implantation.DesignCost-effectiveness analysis.ParticipantsA 67-year-old man with 20/60 vision undergoing evaluation for first-eye cataract surgery.MethodsThe cost-effectiveness analysis of the reference patient undergoing a preoperative cataract examination with and without a screening OCT was performed, evaluating for vitreoretinal diseases including an epiretinal membrane, age-related macular degeneration, vitreomacular traction, and cystoid macular edema. It was assumed that patients with macular pathologies detected before surgery would receive a monofocal IOL and be referred to a retina specialist for evaluation and management. The Medicare reimbursable cost of an OCT was $41.81. All costs and benefits were adjusted for inflation to 2019 United States dollars and discounted 3% per annum over a 16-year time horizon. Probability sensitivity analyses and 1-way deterministic sensitivity analyses were performed to assess for uncertainty.Main outcome measuresIncremental cost-effectiveness ratio and incremental cost-utility ratio (ICUR) measured in quality-adjusted life years (QALYs).ResultsApproximately 20.5% of patients undergoing cataract surgery may have macular pathologies, of which 11% may not be detected on the initial clinical examination. In the base case, an adjunctive preoperative OCT was cost effective from a third-party payer and societal perspective in the United States. In the probability sensitivity analyses, the ICURs were within the societal willingness-to-pay threshold of $50 000/QALY in approximately 64.4% of the clinical scenarios.ConclusionsA preoperative screening OCT during the evaluation of a patient considering a multifocal IOL added to the costs of the cataract surgery, but the OCT increased the detection of macular pathologies and improved the QALYs over time. An adjunctive screening OCT can be cost effective from a third-party payer and societal perspective.