CompletedNot Applicable

621 Real World Study

China105 participantsStarted 2023-01-09

Plain-language summary

This study is evaluating the clinical safety and effectiveness of 621, after cataract surgery.

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Age ≥ 18 years old;
✓. Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag;
✓. Preoperative corneal astigmatism ≤ 1.00D;
✓. Patient is willing and capable of providing informed consent;
✓. Patient is willing and capable of complying with visits and procedures as defined by this protocol.

✕. Preoperative best corrected visual acuity \> 4.7 or ≤ 0.3 logMAR;
✕. Corneal endothelial cell count less than 2000 cell/mm2;
✕. Age under 18 years old;
✕. Pregnant and lactating women;
✕. Patients who attend other drug or medical device study;
✕. Ocular disorder that could potentially cause a clinically significant future visual acuity loss;
✕. Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.)
✕. Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies);

Corrected Distance Visual Acuity (CDVA)

Timeframe: 6 months

NCT IDNCT05646004

SponsorCarl Zeiss Meditec AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-11-27