A Non-Interventional, Prospective, Clinical Study Of The Performance Of An Enhanced Monofocal Intraocular Lens In Patients Undergoing Cataract Surgery: Interim Analysis
Published 2025 - 43rd Congress of the ESCRS
Reference: PP13.09 | Type: Free paper | DOI: 10.82333/8dv8-8n19
Authors: Kepa Balparda* 1 , Laura Martínez-Cadavid 2 , Andrea Ocampo-Patiño 2 , María Isabel Maya-Naranjo 2 , Sara Mesa-Mesa 2 , Jesús David Marulanda-Uribe 3 , Tatiana Herrera-Chalarca 4 , Jorge Hernando Donado-Gómez 5
1Private Practice,Medellin,Colombia, 2Department of Ophthalmology,Universidad Pontificia Bolivariana,Medellin,Colombia, 3Department of Ophthalmology,Pontificia Universidad Javeriana,Cali,Colombia, 4Department of Clinical Research,Black Mammoth Surgical,Medellin,Colombia, 5Department of Research,Hospital Pablo Tobón Uribe,Medellin,Colombia
Purpose
The aim of this study was to evaluate the real-world performance looking at visual outcomes, patient satisfaction, and safety of a new enhanced monofocal intraocular lens (IOL).
Setting
This study was conducted across seven sites in the USA from May to October 2024 (NCT06333028).
Methods
This was a non-interventional, prospective, single-arm, clinical study of an enhanced monofocal enVista ASPIRE™ (EA) IOL in patients undergoing cataract surgery. Patients (≥22 years old; no serious ocular or systemic disease) were enrolled after bilateral implantation of the EA IOL, with postoperative best-corrected distance visual acuity (BCDVA) ≥20/40. The primary outcome was binocular BCDVA. Secondary assessments included binocular distance-corrected intermediate and near visual acuity (DCIVA, DCNVA), defocus curves, patient-reported outcomes (Assessment of Intraocular Lens Implant Symptoms [AIOLIS] and Near Activity Visual Questionnaire), and safety.
Results
This interim analysis included 60 eyes of 30 patients (mean±SD age 69.8±9.15 years, 80.0% Caucasian; 66.7% female). At the study visit (60–270 days after surgery of the second eye), mean±SD binocular BCDVA was −0.042±0.08 logMAR. Mean±SD binocular DCIVA was 0.172±0.13 logMAR, with 66.7% achieving 20/32 or better. Mean binocular defocus curve was −1.25D for visual acuity of 0.2 logMAR or better. AIOLIS survey results showed that <10% of patients reported being “somewhat bothered” by visual disturbances, while 66% rated their vision as “very good” or “excellent”. Three AEs were reported: diabetic retinopathy (2 eyes) and iritis (1 eye), both unrelated to the study lens. No serious adverse events or discontinuations occurred.
Conclusions
This study analysis found that patients implanted with the EA IOL achieved excellent binocular BCDVA (better than 20/20) and binocular intermediate vision (better than 20/32) at ≥60 days post-cataract surgery. Patients also exhibited a mean broad depth of focus of 1.25D and reported high satisfaction with visual outcomes. These findings further support enhanced monofocal IOLs as a treatment option for patients with cataracts seeking expanded visual range and flexibility.