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Study of Intraocular Lens Constants for the Intraocular Lens HOYA Vivinex Impress Implanted Eyes

Study of Intraocular Lens Constants for the Intraocular Lens HOYA Vivinex Impress Implanted Eyes

563

A total of 563 eyes implanted with HOYA Vivinex Impress (XY1-EM) collected from 21 institutions were included in the analysis. The mean age was 74.5 years (SD 7.3). Of the analyzed eyes, 353 (62.7%) were from female patients and 209 (37.1%) were from male patients. The mean axial length was 23.76 mm (SD 1.28).

A total of 563 eyes collected from 21 institutions were included in the analysis. For the primary endpoint, eyes with subjective refraction data available at 1 month postoperatively were used for IOL constant optimization. For secondary endpoints, predefined analysis populations were established according to each evaluation parameter.

No intraoperative device-related complications or adverse events were reported.

IOL constants were calculated according to ocular biometry device and IOL power calculation formula. For the SRK/T formula, the mean A-constants were 119.11 for IOLMaster, 118.48 for OA-2000 (contact mode), and 118.93 for ARGOS. For the secondary endpoints, uncorrected and corrected distance visual acuity improved from the early postoperative period and remained stable from 1 week after surgery. Refractive error also stabilized from postoperative week 1 onward. At 1 month postoperatively, 79.3% of eyes achieved a refractive prediction error within 0.5 D and 95.9% within 1.0 D.

In 563 eyes implanted with HOYA Vivinex Impress (XY1-EM), IOL constants were optimized according to ocular biometry device and IOL power calculation formula, and postoperative visual function and refractive stability were evaluated. Uncorrected and corrected distance visual acuity improved from the early postoperative period and remained stable from 1 week after surgery. Refractive error also stabilized from postoperative week 1 onward, and high refractive prediction accuracy was confirmed at 1 month postop

No

https://jrct.mhlw.go.jp/latest-detail/jRCT1032240342

Osakabe Yasuhiro

HOYA CORPORATION Medical Division

Nakano Central Park South Building 6F 4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan

yasuhiro.osakabe@hoya.com

Goto Yusuke

HOYA CORPORATION Medical Division

Nakano Central Park South Building 6F 4-10-2 Nakano, Nakano-ku, Tokyo 164-8545 Japan

+81-359132347

yusuke.goto@hoya.com

Complete

Sept. 18, 2024

Observational

1) Patients who are 22 years old or older and who are undergoing cataract extraction with phacoemulsification and aspiration
2) Patients who are having XY1-EM implanted
3) Patients whose calculated spherical lens power is +6.0 D or higher and +30.0 D or lower
4) Patients whose postoperative corrected visual acuity can be expected to be 0.7 or better
5) Patients whose preoperative corneal astigmatism is below 1.0 D
6) Patients who can be followed-up with after surgery

1) Patients who are having another ophthalmologic surgery within one month after the intraocular lens implantation
2) Patients who have a history of refractive surgery
3) Patients who have a history of any eye disease or ocular comorbidities that significantly affect their visual function
4) Patients who the principal investigator, etc., deems not appropriate as a study subject due to an accompanying general disease or eye disease

Both

Cataract

IOL constant per intraocular lens formula by biometers

1) Transition of uncorrected distance visual acuity
2) Post-op month 1 uncorrected intermediate visual acuity
3) Post-op month 1 uncorrected near visual acuity
4) Transition of postoperative refractive errors
5) Defects and adverse events

+81-3-6416-1868

Mar. 07, 2024

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