CTRI/2021/11/037924
Recruiting
未知
Prospective evaluation of the clinical safety and effectiveness of hydrophilic acrylic intraocular lens. - UVEA 809
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Health Condition 1: H259- Unspecified age-related cataract
- Sponsor
- Carl Zeiss Meditec AG
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Patients of any gender, aged 18 years or older
- •2\. Patient is planned for aged\-related cataract surgery and implantation of the
- •study IOL into the capsular bag in at least one eye
- •3\. Patient is willing and capable of providing informed consent
- •4\. Patient is willing and capable of complying with visits and procedures as
- •defined by this protocol
Exclusion Criteria
- •1\. Preoperative corrected distance visual acuity (CDVA) better than 0\.3
- •logMAR (0\.5 decimal)
- •2\. Endothelial cell count of less than 2000/mm2
- •3\. Ocular disorder that could potentially cause a clinically significant future
- •visual acuity loss
- •4\. Preoperative corneal astigmatism ââ?°Â¥ 1 D or preoperative corneal
- •astigmatism ââ?°Â¥ 1\.5 D, if postoperative corneal astigmatism is not estimated
- •to be \< 1 D.
- •5\. Clinically significant anterior segment pathology (e.g. chronic uveitis, iritis,
- •aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation,
Outcomes
Primary Outcomes
Not specified
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