Objective: The purpose of the study is to investigate the rate and degree of ocular-hypertensive response to topical steroids in Chinese children.
Design: The study design was an institutional, randomized, clinical trial.
Participants: A total of 19 consecutive patients were studied.
Intervention: Topical steroids were administered to Chinese children younger than 10 years of age who underwent bilateral strabismus surgery. One eye was randomized to receive topical 0.1% dexamethasone (DMS), whereas the fellow eye received 0.1% fluorometholone (FML) six times per day for up to 4 weeks. Intraocular pressure (IOP) was measured on the day before operation and at postoperative days 1, 3, 6, 10, 13, and 27, then every 2 weeks thereafter until the IOP fell to preoperative levels. Topical steroids would be stopped if IOP was 30.00 mmHg or greater.
Main outcome measures: Peak IOP and maximal change of IOP from baseline were measured and categorized into low, intermediate, and high levels. Time to peak IOP also was studied.
Results: A total of 16 patients were included. The peak IOP for DMS-treated eyes was 30.66 +/- 8.35 mmHg (range, 13.00-48.00 mmHg), whereas that in FML-treated eyes was significantly lower at 20.66 +/- 6.03 mmHg (range, 11.30-36.30 mmHg) (P = 0.001). The maximal change in IOP ranged from -2.60 to +31.00 mmHg in DMS-treated eyes (mean, 15.48 +/- 8.71 mmHg), almost double that of FML-treated eyes (range, +1.00 to +17.00 mmHg; mean, 5.83 +/- 4.96 mmHg) (P = 0.001). When the ocular-hypertensive responses of both DMS and FML groups were categorized into three levels of severity, significant differences were found between the two treatment groups (P = 0.001). In the DMS group, nine patients (56.25%) were high responders and six patients (37.5%) were intermediate responders. In the FML group, only one patient (6.25%) was a high responder.
Conclusions: The ocular-hypertensive response to topical DMS in children occurs more frequently, more severely, and more rapidly than that reported in adults. A total of 56% of the studied children, all younger than 10 years of age, were high responders to topical DMS. Of these, 89% attained their peak IOP within 8 days. Its use in children should best be avoided if possible. It would be desirable to monitor the IOP when it is being used. Conversely, FML produced a much less ocular-hypertensive effect and therefore poses an acceptable risk of clinically significant pressure elevation.