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Randomized Controlled Trial
. 2024 May;38(Suppl 1):9-14.
doi: 10.1038/s41433-024-03039-8. Epub 2024 Apr 5.

Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens

Dean Corbett  1 , Daniel Black  2 , Timothy V Roberts  3   4 , Brendan Cronin  5 , David Gunn  5 , Chandra Bala  6 , Patrick Versace  7 , Linda Tsai  8 , Eleni Papadatou  8 , Aixa Alarcon  9 , Srividhya Vilupuru  10
Affiliations
Randomized Controlled Trial

Quality of vision clinical outcomes for a new fully-refractive extended depth of focus Intraocular Lens

Dean Corbett et al. Eye (Lond). 2024 May.

Erratum in

Abstract

Background/objective: To evaluate the visual performance of a purely refractive extended depth of focus (EDF) intraocular lens (IOL).

Subjects/methods: A prospective, multi-center, randomized, subject/evaluator-masked study. Subjects were bilaterally implanted with the EDF test (Model ZEN00V, TECNIS PureSee™ IOL, N = 60) or an enhanced monofocal control (Model ICB00, TECNIS Eyhance™ IOL, N = 57) IOL. Monocular corrected distance (CDVA), intermediate (DCIVA), near acuities (DCNVA) and patient reported visual symptoms were evaluated at the 6-month visit. Monocular mesopic contrast sensitivity (CS) and depth of focus (DOF) testing were assessed at 3 months.

Results: CDVA (Mean ± SD) was -0.06 ± 0.08 for test and -0.05 ± 0.08 logMAR for control groups. DCIVA was 0.13 ± 0.08 for test and 0.18 ± 0.14 logMAR for control groups (p = 0.0127). DCNVA was 0.37 ± 0.10 for test and 0.43 ± 0.16 logMAR for control groups (p = 0.0137). Test lens was statistically superior for intermediate and near. Overall, 91.7% (halos), 95.0% (starbursts) and 95.0% (glare) of test lens patients reported that they did not experience, were not bothered, or were slightly bothered by specific visual symptoms, compared to 98.2%, 100% and 96.5% in the control group. The DOF range over which monocular visual acuity was 0.20 logMAR or better was -1.6 D for the test lens. Mesopic CS was comparable between both groups, falling within 0.11 log units for all measured cycles per degree with and without glare.

Conclusion: The EDF IOL demonstrated extended range of vision and statistically superior intermediate and near performance compared to the monofocal IOL. Distance visual acuity, contrast sensitivity and dysphotopsia profile were similar to the monofocal IOL.

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Conflict of interest statement

DC: None. DB: Consultant to, and performs research supported by, Johnson & Johnson Surgical Vision, Inc. CB: Consultant to, and performs research supported by, Johnson & Johnson Surgical Vision, Inc. and Alcon. TVR: Received investigator grants from J&J Vision and Alcon, and participated on advisory boards for Alcon, J&J Vision, Glaukos and Hoya. BC: Received consulting fees from Glaukos, Allergan, and J&J Vision. DG: Received consulting fees from Alcon and participated on paid advisory boards and as a speaker for Alcon. PV: Received clinical trial funding from J&J Vision, paid medical advisor for Teleon, Germany, participated on paid advisory boards for J&J Vision, and received speaker fees from STAAR Surgical. LT, EP, AA, and SV: Employees of Johnson & Johnson Surgical Vision, Inc.

Figures

Fig. 1
Fig. 1. Level of bothersome (%) for ocular visual symptoms, including halos (top graph), glare (middle graph), and starbursts (bottom graph), acquired with PRVSQ at 6 months for ZEN00V, ICB00, and ZCB00 (historical control) bilaterally implanted patients.
‘NR’ indicates no response.
Fig. 2
Fig. 2. Mean monocular, distance corrected contrast sensitivity under mesopic lighting conditions without glare (top graph), and with glare (bottom graph) for first eyes at 3 months for ZEN00V and ICB00.
Error bars represent ±SD.
Fig. 3
Fig. 3. Mean monocular, distance corrected defocus curves at 3 months for ZEN00V and ICB00 ranging from +1.00 D to −2.50 D and at 6 months for ZCB00 (historical control), ranging from +1.00 D to −2.50 D.
The defocus curve for ZEN00V from +1.00 D to −2.50 D, obtained with maximum plus refraction (MPMVA) sub-study, is also depicted. Error bars represent ±SE.
See this image and copyright information in PMC

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