Evaluation of visual function after implantation of Impress intraocular lens

JRCT ID: jRCT1072240010

Registered date:27/04/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Cataract
• Date of first enrollment: 02/03/2024
• Target sample size: 25
• Study type: Interventional

Intervention(s)

A group: Implantation of HOYA Vivinex iSert XY 1-EM IOL
B group: Implantation of HOYA Vivinex iSert XY1-XY1 IOL

Outcome(s)

• Primary Outcome: Uncorrected/ corrected all-distance visual acuity at 3 months after surgery (binocular visual acuity)

Secondary Outcome

1) Uncorrected/ corrected all-distance visual acuity at 3 months after surgery (monocular visual acuity)
2) Contrast sensitivity at 3 months after surgery
3) Evaluation of QOV (questionnaire)
4) Prescription rate of glasses
5) Incidence of surface scattering

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1)Patients with cataracts
2)Patients with corneal astigmatism not exceeding 1.0D
3)Patients with axial length between 22 and 26mm
4)Patients desiring binocular emmetropia
5)Patients signed the informed consent form
6)Patients scheduled for second eye cataract surgery within 30 days after first eye cataract surgery

Exclude criteria

1)Patients with or suspected to have disease affecting visual acuity except for cataract at the time of preoperative examination in the study eye
2)Patients who are regarded as unsuitable for this study by the investigator
3)Patients expressed refusal to participate in this study
4)Patients who do not meet the foregoing inclusion criteria
5) Patients in whom intraoperative complications affecting visual acuity have occurred, except for the preoperative exclusion criteria mentioned above

Related Information

• Primary Sponsor: Mori Yosai