Recent clinical trials of blue-light-filtering intraocular lenses have yielded remarkable results for the medical community. The trial used a prospective, multicenter, randomized, open-label, positive parallel control design using the Acrysof IQ intraocular lens hydrophobic acrylate product manufactured by Alcon in the United States. Let's dive into the key data and results of the trial.
Main evaluation index: corrected distance visual acuity
One of the main evaluation measures in the trial was the percentage of best-corrected distance visual acuity of 20 to 40 at 6 months postoperatively. In the full sample set (FAS), the experimental group performed 100% compared to 9663%。This shows that the declared product has a significant advantage in correcting distance vision. The difference is 337% with a 95% confidence interval of (-0.).38%,7.12%)，p<0.001, the lower limit of the confidence interval is greater than -10%, which further consolidates the superiority of the experimental group.
Consistency of efficacy and safety
The results of the secondary evaluation indicators showed that there was no significant difference between the experimental group and the control group in the best corrected distance visual acuity and unaided distance visual acuity at 1 day, 1 week, 1 month, 3 months, 6 months, and 12 months after surgery, indicating that the visual acuity of both groups was maintained at a satisfactory level. In terms of diopters, the performance of both groups was within the acceptable range, with a difference of less than 0 from the expected diopter5d, which meets the clinical needs.
Safety evaluation
In terms of safety evaluation, there were no device defects in the experimental group, and the incidence of serious adverse events was comparable to that in the control group, which was within a controllable range. This shows that there is no significant safety disadvantage to the implantation of blue-light-filtering intraocular lenses.
Conclusion
The data results of the clinical trial of the blue light filtering intraocular lens showed that the declared product performed well compared with the control product in terms of corrected distance vision, refraction and safety. This provides strong support for the introduction of more advanced and safer technologies in the field of eye surgery in the future. This medical innovation is expected to bring a better quality of life to more patients in need of vision correction and inject new vitality into the development of ophthalmology.