Post-Market Clinical Study of the Clareon® AutonoMe™ with Korean Populatio
- Conditions
- Diseases of the eye and adnexa
- Registration Number
- KCT0004634
- Lead Sponsor
- Alcon Korea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 175
1. 20 years of age or older at the time of informed consent, of either gender in Korea, who were diagnosed with age-related unilateral or bilateral cataracts and willing to undergo cataract extraction.
2. Able to comprehend and willing to sign informed consent and complete all required postoperative follow-up procedures.
3. Calculated lens power between +15.0 and +30.0 D in both eyes.
4. Preoperative regular corneal astigmatism of < 1.00 D.
1. Subjects fulfilling any of the following criteria are not eligible for participation in this study:
a.currently pregnant
b.have a positive urine pregnancy test result at screening
c.intend to become pregnant during the study period
d.are currently breast-feeding
Subjects who become pregnant after a study IOL/AutonoMe device has touched the eye will not be discontinued; however, data will be excluded from the effectiveness analyses from that point forward because pregnancy can alter refraction and visual acuity results.
2. Clinically significant corneal abnormalities including corneal dystrophy, corneal degenerations, inflammation, or edema per the Investigator’s expert medical opinion.
3. Previous corneal transplant.
4.Ocular trauma, previous refractive surgery, or refractive procedures throughout the entire duration of the subjects’ participation in the clinical study (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incision).
5. History of or concurrent retinal conditions or predisposition to retinal conditions, diagnosed degenerative eye disorder such as macular degeneration, previous history of, or a predisposition to, retinal detachment or presence of diabetic retinopathy that the Investigator judges could confound outcomes. (NOTE: Including but not limited to background diabetic retinopathy, diabetic macular edema, or proliferative diabetic retinopathy, macular degeneration).
6. Amblyopia.
7. Rubella, congenital, traumatic, or complicated cataract.
8. Any other conditions (ocular or non-ocular), that may deteriorate the surgical outcome, including but not limited to those in existing literature, based on the Investigator’s expert medical opinion.
9. Diagnosed glaucoma (uncontrolled or controlled with medication).
10. Subjects currently participating in another clinical study.
11. Any current anterior or posterior segment inflammation of any etiology, and/or history of any disease producing an intraocular inflammatory reaction.
12. Iris neovascularization.
13. Extremely shallow anterior chamber, not due to swollen cataract.
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of eyes achieving monocular BCDVA of 0.2 logMAR or better in photopic conditions
- Secondary Outcome Measures
Name Time Method 1.Difference between predicted refraction and manifest refraction (spherical equivalent);2.Monocular UCDVA in photopic conditions;3.Monocular BCDVA in photopic conditions