Evaluation of refractive stability of Clareon intraocular lens

Not Applicable

• Conditions: binocular cataract

• Registration Number: JPRN-jRCTs042200009
• Lead Sponsor: akano Shinichirou

Brief Summary

Clareon IOL was inserted in one eye and AcrySof IOL in another eye, and postoperative refractive stability was compared. (1)Average range of changes in anterior chamber depth Clareon: -0.156 to -0.100mm AcrySof: -0.141 to -0.116mm (2)Average range of tilt Clareon: 4.0-4.2 degree AcrySof: 3.9-4.1 degree (3)Average range of decentration Clareon: 0.13-0.18mm AcrySof: 0.14-0.24mm These results suggest that Clareon IOL is an IOL with excellent postoperative refractive stability, similar to AcrySof IOL.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-05-13
• Study Completion: 2022-09-12
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 34

Inclusion 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.

Exclusion 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in anterior chamber depth ( 1 day to 6 months after surgery)

Secondary Outcome Measures

Name	Time	Method
Best corrected vision<br>Subjective and objective refraction values<br>Deccentration and tilting of IOL<br>Frequency of adverse events / Failure frequency