Bilateral implantation of +2.5 D multifocal intraocular lens and contralateral implantation of +2.5 D and +3.0 D multifocal intraocular lenses: Clinical outcomes

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• 作者：Rudy M.M.A. Nuijts ; MD ; PhD ; Soraya M.R. Jonker ; MD ; ^{soraya.jonker@mumc.nl" class="auth_mail" title="E-mail the corresponding author} ; Robert A. Kaufer ; MD ; Ruth Lapid-Gortzak ; MD ; PhD ; Javier Mendicute ; MD ; PhD ; Cristina Peris Martinez ; MD ; PhD ; Stefanie Schmickler ; MD ; Thomas Kohnen ; MD ; PhD ; FEBO
• 刊名：Journal of Cataract & Refractive Surgery
• 出版年：2016
• 出版时间：February 2016
• 年：2016
• 卷：42
• 期：2
• 页码：194-202
• 全文大小：737 K

文摘

To assess the clinical visual outcomes of bilateral implantation of Restor +2.5 diopter (D) multifocal intraocular lenses (IOLs) and contralateral implantation of a Restor +2.5 D multifocal IOL in the dominant eye and Restor +3.0 D multifocal IOL in the fellow eye.

Setting

Multicenter study at 8 investigative sites.

Design

Prospective randomized parallel-group patient-masked 2-arm study.

Methods

This study comprised adults requiring bilateral cataract extraction followed by multifocal IOL implantation. The primary endpoint was corrected intermediate visual acuity (CIVA) at 60 cm, and the secondary endpoint was corrected near visual acuity (CNVA) at 40 cm. Both endpoints were measured 3 months after implantation with a noninferiority margin of Δ = 0.1 logMAR.

Results

In total, 103 patients completed the study (53 bilateral, 50 contralateral). At 3 months, the mean CIVA at 60 cm was 0.13 logMAR and 0.10 logMAR in the bilateral group and contralateral group, respectively (difference 0.04 logMAR), achieving noninferiority. Noninferiority was not attained for CNVA at 40 cm; mean values at 3 months for bilateral and contralateral implantation were 0.26 logMAR and 0.11 logMAR, respectively (difference 0.15 logMAR). Binocular defocus curves suggested similar performance in distance vision between the 2 groups. Treatment-emergent ocular adverse events rates were similar between the groups.

Conclusion

Bilateral implantation of the +2.5 D multifocal IOL resulted in similar distance as contralateral implantation of the +2.5 D multifocal IOL and +3.0 D multifocal IOL for intermediate vision (60 cm), while noninferiority was not achieved for near distances (40 cm).