Purpose
Mydriasert is a relatively new drug-eluting pellet used for pre-operative mydriasis.Its efficacy has been demonstrated in a clinical trial setting where many exclusion criteria have been applied.There are conflicting reports about its efficacy in patients with diabetes mellitus.We performed a prospective,observational study to report the "real-world" efficacy and stability of mydriasis using the mydriasert in a UK district general hospital and to assess its efficacy in patients with diabetes mellitus.
Methods
100 consecutive patients undergoing cataract surgery were identified.9 patients declined to participate.91 patients were enrolled.All patients were dilated pre-operatively with the mydriasert device.Pupil diameters at the start and end of surgery were recorded.Any intraoperative measures to increase pupil diameter were recorded.
Results
Mean pupil diameter at the start of surgery was 7.9+/-1.1 mm.The mean reduction in pupil size during surgery was 1.3+/-0.9mm.The majority of this reduction occurred during irrigation/aspiration after lens implantation.<br /> Six patients(6.6%) required interventions to increase pupil size.Mean pupil size at the start of surgery in this group was 5.5+/-1.1mm.Four of these patients were given intracameral phenylephrine,one required iris hooks and another required iris hooks after inadequate effect from intracameral phenylephrine.<br /> Diabetes mellitus was present in 25% of the patients(n=23) in this series.Mean pupil diameter at the start and end of surgery was 7.8+/-1.0mm and 6.7+/-1.4mm respectively.For patients without diabetes, these values were 7.8+/-1.2mm and 6.3+/-1.3mm.78% of patients with diabetes mellitus achieved a pupil diameter of ≥7mm. In those without diabetes, 82% had a pupil diameter ≥ 7mm.There was no clinically significant difference in pupil size at the start and end of surgery in diabetic and non-diabetic subgroups.
Conclusions
This is the largest prospective series looking at the use of the mydriasert in an unselected population of patients undergoing cataract surgery and has the largest subgroup of diabetic patients to date.These results demonstrate,using “real-world’ data,that the mydriasert produces effective and stable mydriasis for cataract surgery and that it is equally efficacious in patients with diabetes mellitus compared to those without.