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

JRCT ID: jRCT1032240342

Registered date:18/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 18/09/2024
• Target sample size: 900
• Study type: Observational

Outcome(s)

• Primary Outcome: IOL constant per intraocular lens formula by biometers

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 22age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

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

Exclude criteria

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

Related Information

• Primary Sponsor: Osakabe Yasuhiro
• Source(s) of Monetary Support: HOYA CORPORATION