A multi-center, randomized, evaluator-blinded, prospective and comparative clinical trial to evaluate the efficacy and safety of the Lens Angle Supporter(LAS) for insertion of an intraocular lens in cataract surgery in cataract patients
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0007870
- Lead Sponsor
- osec
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 33
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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method An independent evaluator evaluated the tilt and decentration of the IOL at the 12th month after application of the clinical trial medical device.
- Secondary Outcome Measures
Name Time Method 1) Evaluation by an independent evaluator of the tilt and decentration of the IOL at the time of evaluation 6 months after application of the clinical trial medical device 2) Evaluation score by independent evaluator of NEI-VFQ 25 (Visual Function Questionnaire 25) evaluated by clinical trial subjects at the 1st, 6th, and 12th month after application of the clinical trial medical device 3) Evaluation of posterior capsule opacity by an independent evaluator at the 1st, 6th, and 12th month after application of the clinical trial medical device 4) The degree of maintenance and exertion of control power evaluated by an independent evaluator at the time of evaluation at the 6th and 12th month after application of the clinical trial medical device