研究目的
To evaluate incidence of posterior capsule opacification requiring Nd:YAG capsulotomy over 3 years in a large series of eyes implanted with the enVista? MX60 Intraocular Lens (IOL).
研究成果
The enVista? MX60 IOL demonstrates a low three-year cumulative incidence of PCO requiring Nd:YAG capsulotomy (2.2%), with no observed glistenings, indicating excellent safety and effectiveness. The design features, such as hydrophobic material and sharp posterior optic edge, likely contribute to this outcome. Future studies should include longitudinal cohorts with comparator groups to validate these findings and explore factors like anti-VEGF therapy's role in PCO prevention.
研究不足
The study is retrospective and single-center, which may introduce selection bias and limit generalizability. The lack of a comparator group with another IOL type makes it difficult to directly attribute the low PCO incidence solely to the enVista? MX60 IOL. The older age of the study population (mean 80.7 years) might influence results, as age can affect PCO development. Additionally, the observational nature means confounding factors could not be fully controlled.
1：Experimental Design and Method Selection:
A retrospective, observational study design was used, analyzing medical records of patients who underwent cataract surgery with enVista? MX60 IOL implantation. The study aimed to assess the rate of Nd:YAG capsulotomy as the primary outcome, with secondary outcomes including time to capsulotomy and incidence of glistenings.
2：Sample Selection and Data Sources:
Patients were selected based on inclusion criteria: uneventful cataract surgery, in-the-bag implantation of enVista? MX60 IOL, and a minimum follow-up of 24 months. Exclusion criteria included insufficient follow-up, intraoperative complications, and combined surgery. Data were sourced from medical records at a single university-based center.
3：List of Experimental Equipment and Materials:
The enVista? MX60 IOL (Bausch & Lomb) was the primary material implanted. Other equipment included standard phacoemulsification tools for surgery and Nd:YAG laser for capsulotomy if needed.
4：Experimental Procedures and Operational Workflow:
Patients underwent standard phacoemulsification cataract surgery with IOL implantation by the same surgeon. Postoperative follow-ups were conducted, and Nd:YAG capsulotomy was performed based on visual acuity, slit-lamp examination, and funduscopy findings indicating PCO. Data on demographics, comorbidities, visual acuity, and capsulotomy events were recorded.
5：Data Analysis Methods:
Statistical analysis used Kaplan-Meier estimates for survival curves, log-rank test, and Cox model to adjust for patient differences (age, sex, comorbidities). SPSS for Windows (version 17.0) was used, with statistical significance set at P < 0.05.
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