Evaluation of refractive stability of Clareon intraocular lens

JRCT ID: jRCTs042200009

Registered date:13/05/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: binocular cataract
• Date of first enrollment: 15/06/2020
• Target sample size: 50
• Study type: Interventional
• Intervention(s): Insert Clareon IOL into one eye and AcrySof IOL into another eye.

Outcome(s)

• Primary Outcome: Change in anterior chamber depth ( 1 day to 6 months after surgery)

Secondary Outcome

Best corrected vision
Subjective and objective refraction values
Deccentration and tilting of IOL
Frequency of adverse events / Failure frequency

Key inclusion & exclusion criteria

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

Include criteria

(1)Patients diagnosed with binocular cataract.
(2)Patients who are planning to insert Clareon IOL or AcrySof IOL and have consent for IOL insertion.
(3)Male and female patients aged 20 years or older when obtaining consent.
(4)Patients who understand the explanation document and obtain written consent at their own will.
(5)Patients who can visit for postoperative observation specified in the study protocol.

Exclude criteria

(1)Patients who are determined by the investigator to need astigmatism correction when obtaining consent.
(2)Patients planning other eye surgery within 6 months after IOL insertion.
(3)Patients with a history or complications of ophthalmic diseases that significantly affect visual function.
(4)Patients with lenticular capsule or Zinn's zonular abnormalities that can induce deccentration or tilting of IOL. (pseudoexfoliation, etc.)
(5)In addition, patients who are judged by the investigator to be inappropriate for the purpose of this study due to systemic or ophthalmic diseases.

Related Information

• Primary Sponsor: Nakano Shinichirou
• Source(s) of Monetary Support: Alcon Japan Ltd.