Performance and Safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) in Phakic Subjects with Presbyopia

Abstract

Purpose: To evaluate the performance and safety of the Extended Depth of Focus Implantable Collamer® Lens (EDOF ICL) for improvement of uncorrected near, intermediate and distance visual acuity in phakic subjects with myopia and presbyopia.

Design: Prospective multicenter study.

Methods: Presbyopic subjects who required an EDOF ICL in the range of -0.50 D to -18.00 D, exhibited ≤ 0.75 D refractive astigmatism and required from +1.00 to +2.50 D reading add were implanted bilaterally. Assessments at 6 months included uncorrected near, intermediate and distance visual acuities, defocus curves, contrast sensitivity, responses to the National Eye Institute Refractive Error Quality of Life Questionnaire and a Task Assessment Questionnaire.

Results: A total of 34 subjects completed the study. Investigators targeted emmetropia in all eyes. Mean binocular uncorrected near, intermediate and distance visual acuities measured logMAR -0.01 ± 0.05 (20/20), -0.02 ± 0.08 (20/19) and 0.07 ± 0.10 (20/23), respectively. Mean monocular uncorrected near, intermediate and distance visual acuities measured logMAR 0.068 ± 0.09 (20/23), 0.062 ± 0.10 (20/23) and 0.16 ± 0.12 (20/29). There were no clinically or statistically significant differences in contrast sensitivity between baseline and 6 months under any testing conditions. Subjects reported significant improvements in measures of vision-related quality of life and ability to perform tasks at all distances without glasses or contact lenses. Overall, satisfaction with the EDOF ICL was high: postoperatively, 91.2% of subjects were satisfied with their vision.

Conclusion: This multicenter, prospective clinical investigation demonstrated the ability of the EDOF ICL to correct myopia and presbyopia, resulting in improvement of uncorrected near, intermediate and distance visual acuity without compromising the quality of vision. The EDOF ICL allowed subjects to perform tasks of daily living without glasses or contact lenses. Subjects reported significant improvements in quality of life with high levels of spectacle independence and satisfaction.

Keywords: implantable Collamer lens; myopia; phakic refractive lens; presbyopia.

Conflict of interest statement

Dr. Packer: Advisor (Advanced Vision Science [Santen], Alcon, Amaros Medical, Aquea Health, Bausch + Lomb, Cassini Technologies, ClearSight, International Biomedical Devices, Keranova, Lensar, LensGen, PhysIOL, Precision for Medicine, Presbia USA, Promedica International, Rayner, Refocus Group, STAAR Surgical, Tarsus Pharmaceuticals, Visant Medical); equity owner (Aerie Pharmaceuticals, Amaros Medical, Aquea Health, Cassini Technologies, ClearSight, Digital Surgery Systems, International Biomedical Devices, Ira, Keranova, LensGen, Refocus Group, STAAR Surgical, Tarsus Pharmaceuticals, TrueVision, Visant Medical). Dr. Alfonso: Research funding (STAAR Surgical). Dr. Aramberri: Advisor (STAAR Surgical, Alcon, Johnson & Johnson, Zeiss). Dr. Elies: Advisor (STAAR Surgical). Dr. Fernandez: Advisor (Medicontur, Carl Zeiss Meditec); research funding (Bausch + Lomb); speakers bureau (STAAR Surgical, Oculus). Dr Mertens: Advisor (PhysIOL, Zeiss, Allotex, VSY, MircoSurgical Technology, Excel-lens, Novoxel, CSO, Ellex, Hoya, Medicontur); equity owner (Excel-lens, Novoxel, STAAR Surgical). The authors report no other conflicts of interest in this work.

© 2020 Packer et al.

Figures

Figure 1

Preoperative and postoperative monocular uncorrected distance visual acuity.

Figure 2

Preoperative and postoperative binocular uncorrected distance visual acuity.

Figure 3

Preoperative and postoperative monocular uncorrected near visual acuity.

Figure 4

Preoperative and postoperative binocular uncorrected near visual acuity.

Figure 5

Preoperative and postoperative monocular uncorrected intermediate visual acuity.

Figure 6

Preoperative and postoperative binocular uncorrected intermediate visual acuity.

Figure 7

Scatterplot of intended versus achieved postoperative manifest spherical equivalent refraction.

Figure 8

Preoperative and postoperative monocular distance corrected near visual acuity for the cohort with preoperative monocular distance corrected near visual acuity 20/40 or worse.

Figure 9

Preoperative and postoperative binocular distance corrected near visual acuity for the cohort with preoperative binocular distance corrected near visual acuity 20/40 or worse.

Figure 10

Preoperative and postoperative monocular distance corrected intermediate visual acuity for the cohort with preoperative monocular distance corrected near visual acuity 20/40 or worse.

Figure 11

Preoperative and postoperative binocular distance corrected intermediate visual acuity for the cohort with preoperative binocular distance corrected near visual acuity 20/40 or worse.

Figure 12

Binocular defocus curve for cohort of subjects with baseline binocular distance corrected near visual acuity 20/40 or worse.

Figure 13

(A–D) Preoperative and postoperative monocular photopic contrast sensitivity without (A) and with (B) glare, and monocular mesopic contrast sensitivity without (C) and with (D) glare.

Figure 14

(A–D) Preoperative and postoperative binocular photopic contrast sensitivity without (A) and with (B) glare, and binocular mesopic contrast sensitivity without (C) and with (D) glare.

Figure 15

Preoperative and postoperative mean Task Assessment Questionnaire scores in good (A) and dim (B) light.