A Summary of the CataPulse® Clinical Study Used to Achieve CE Approval
About the Investigator
Dr. Antonio Mendez Noble is the director of the Vision Mendez Institute. He and his staff have been operating for more than 25 years in the field of refractive surgery. His subspecialties include cornea, external disease, and refractive surgery. He is an expert in advanced techniques and regularly treats cataracts and performs LASIK and cornea transplantation.
A wide variety of of subjects with different ages and grades of cataracts were recruited for this study. The average age of the treated subjects was 65 and ranged from 46 to 83 years of age. Of the 73 subjects enrolled, 28 were male and 45 were female. All subjects had visually symptomatic age-related cataracts ranging from Grade 1 through Grade 4, according to LOCS II.
The 73 subjects of the study were scheduled to be evaluated at baseline, 1 day, 15 days, and 30 days post-op. All but two subjects were evaluated as scheduled. Two subjects missed the 15 day follow-up but were evaluated at baseline, 1 day, and 30 days. There were zero adverse events or complications throughout the study.
In the postoperative examinations, all subjects had clear corneas the following day, with only 13 showing minor signs of edema on day 1 postop. All patients successfully achieved at least 20/40 uncorrected visual acuity, with 93% achieving 20/30 or better. The average endothelial cell loss at day 30 was 2.86% with a 1.22% standard deviation.
Using the CataPulse®, there is a significant reduction in endothelial cell loss when compared to the percentage loss of endothelial cells documented in studies* showing endothelial cell loss when ultrasound is used. Less endothelial cell loss means a greater long term health of the cornea, which corresponds to a higher quality of life and happier patients.