CTRI/2020/09/027637
Completed
未知
A Comparative Clinical Evaluation of the Safety and Effectiveness of a Monofocal Extended Depth of Focus Intraocular Lens for the Correction of Aphakia
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H268- Other specified cataract
- Sponsor
- Advanced Vision Science Inc
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults 40 years of age and older at the time of consent.
- •2\. Cataract in both eyes.
- •3\. Pre\-operative corneal astigmatism \< 1\.0 D.
- •4\. Calculated lens power from 18 D to 24 D.
- •5\. Willing and able to return for all scheduled treatment and post\-operative visits for a minimum of 6 months.
- •6\. Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by manual phacoemulsification cataract extraction in both eyes.
- •7\. Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery.
- •8\. Preoperative best corrected distance visual acuity (BCDVA) of 0\.2 logMAR or worse, with or without a glare source.
- •9\. Post\-operative BCDVA projected to be 0\.2 logMAR or better (as determined by the medical judgment of
- •the Investigator or measured by potential acuity meter / retinal acuity meter (PAM / RAM) if necessary).
Exclusion Criteria
- •1\. Participation in any other drug or device clinical trial within 90 days prior to enrolling in this study and/or during study participation.
- •2\. Pregnancy or lactation.
- •3\. Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms \- CRF).
- •4\. Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
- •5\. History of any intraocular or corneal surgery in either eye (including LASIK, PRK, LRI, etc.).
- •6\. Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye.
- •7\. Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis, aniridia, rubeosis iridis, clinically significant corneal, Fuchs,anterior membrane distrophis,etc) in either eye.
- •8\. Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
- •9\. Any visually significant intraocular media opacity other than cataract in either eye.
- •10\. History of any clinically significant retinal pathology or ocular diagnosis (e.g., diabetic retinopathy, ischemic
Outcomes
Primary Outcomes
Not specified
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