None listed
Conditions
Interventions
Procedure/Surgery : - Test group: intraocular lens support (LAS) and intraocular lens (CLARE®) were inserted into one randomly assigned eye
- Control group: Insert only an intraocular lens (CLARE®) in
Sponsors
Losec
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Selection Criteria 1) Adult male and female patients aged 19 to 75 years 2) Based on the cataract classification tool LOCS ?, among patients with cataract progression stage 2 or higher, patients requiring cataract surgery in both eyes 3) Those who do not have clinically significant abnormalities in blood test before surgery 4) Those who can participate during the clinical trial 5) Those who voluntarily sign or seal the subject's consent for research participation
Exclusion criteria
Exclusion criteria: 1) Patients who have previously had surgery on the surgical site 2) Patients with eye trauma or a history of trauma 3) If the capsular bag or platoon is ruptured or there is a risk of rupture when inserting the product 4) When an infectious disease is in progress in a part or tissue 5) If there is a history of chronic or recurrent uveitis or similar 6) Subjects with the following diseases are not eligible to participate in the clinical trial. - Congenital binocular cataract, medically incurable glaucoma patient, microophthalmos, recurrent inflammatory glomerulonephritis, anterior chamber collapse, proliferative diabetic retinopathy, endothelial dystrophy, acute eye disease 7) If you are pregnant or lactating 8) If it is related to the researcher involved in clinical evaluation 9) In case the investigator judges that it is not suitable to participate in the clinical trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| An independent evaluator evaluated the tilt and decentration of the IOL at the 12th month after application of the clinical trial medical device. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Independent evaluator's assessment of tilt and decentration of the intraocular lens at the 6-month evaluation point after application of the clinical trial medical device 2) NEI-VFQ 25 (Visual Function Questionnaire 25) score assessed by the clinical trial subject at the 1-month, 6-month, and 12-month evaluation points after application of the clinical trial medical device 3) Evaluation of posterior capsule opacity by the evaluator at the 1-month, 6-month, and 12-month evaluation points after application of the clinical trial medical device 4) Maintenance and exertion of accommodative power assessed by the evaluator at the 6-month and 12-month evaluation points after application of the clinical trial medical device | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun Seung Kim
The Catholic University of Korea, Yeouido St. Mary's Hospital
Outcome results
None listed