JRCT ID: jRCTs042200009
Registered date:13/05/2020
Evaluation of refractive stability of Clareon intraocular lens
Basic Information
Recruitment status | Complete |
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Health condition(s) or Problem(s) studied | binocular cataract |
Date of first enrollment | 15/06/2020 |
Target sample size | 50 |
Countries of recruitment | |
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) |
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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 |
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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 |
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Secondary Sponsor | |
Source(s) of Monetary Support | Alcon Japan Ltd. |
Secondary ID(s) |
Contact
Public contact | |
Name | Shinichirou Nakano |
Address | 1-1 Nakazato, Ryugasaki shi, Ibaraki, Japan Ibaraki Japan 301-0854 |
Telephone | +81-297-63-7111 |
nakanoryugasaki@yahoo.co.jp | |
Affiliation | Ryugasaki Saiseikai Hospital |
Scientific contact | |
Name | Shinichirou Nakano |
Address | 1-1 Nakazato, Ryugasaki shi, Ibaraki, Japan Ibaraki Japan 301-0854 |
Telephone | +81-297-63-7111 |
nakanoryugasaki@yahoo.co.jp | |
Affiliation | Ryugasaki Saiseikai Hospital |