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CLINICAL TRIAL REPORT

Clinical Outcomes of a Bi-Aspheric Trifocal Diffractive Intraocular Lens

, , , , &
Pages 27-40 | Received 13 Nov 2023, Accepted 20 Dec 2023, Published online: 04 Jan 2024
 

Abstract

Purpose

To assess refractive and visual outcomes post-cataract surgery with bilateral implantation of a bi-aspheric diffractive trifocal intraocular lens (IOL).

Methods

A total of 24 patients who underwent bilateral implantation with the Asqelio Trifocal IOL TFLIO130C were evaluated at the 6 months postoperative mark. Key outcome measures included refractive error, photopic monocular and binocular uncorrected and corrected distance visual acuity (UDVA, CDVA), uncorrected and corrected intermediate visual acuity (UIVA, CDIVA) at 60 cm, and uncorrected and corrected near visual acuity (UNVA, CDNVA) at 40 cm. Additionally, monocular and binocular CDNVA were assessed under mesopic conditions. Monocular and binocular defocus curves, and binocular contrast sensitivity under photopic and mesopic conditions, with and without glare, were measured. Catquest-9SF and visual symptoms questionnaires were also administered.

Results

Postoperative average values of binocular logMAR photopic CDVA, photopic CDIVA, photopic CDNVA and mesopic CDNVA were −0.01±0.06, 0.03±0.09, 0.02±0.05 and 0.19±0.13, respectively. About 100% of patients showed cumulative CDVA and CDNVA ≥20/25, and CDIVA ≥20/32. The average absolute depth-of-focus was about 4.50D. The average postoperative spherical equivalent was 0.05±0.30D and 100% and 93.75% eyes were within ±1.00D and ±0.50D, respectively. Contrast sensitivity was either within or above normal levels under both photopic and mesopic conditions, both with and without glare, except for 12 cpd under mesopic conditions with glare where the mean falls just below the normal range. Questionnaires revealed that 87.5% of patients were either satisfied or very satisfied with their vision after the surgery, and higher percentages for no difficulty in performing different activities, ranging from 70.83% to 95.83%, were reported.

Conclusion

This study demonstrates that the bi-aspheric diffractive trifocal IOL yields very good visual performance across distances, fostering high satisfaction levels and minimal difficulties in daily activities.

Data Sharing Statement

The data are not available for sharing.

Disclosure

Dr Pedro Tañá-Rivero reports grants from AST Products Inc, during the conduct of the study; grants from Alcon Labs, grants from Carl Zeiss Meditec, grants from Heidelberg Engineering, grants from Hoya Surgical, grants from Humanoptics Holding, grants from Johnson&Johnson, grants from BVI, grants from Staar Surgical, outside the submitted work. The authors report no other conflicts of interest in this work.

Additional information

Funding

This study has been funded by AST Products, Inc. (Billerica, MA, USA).