Ocular-hypertensive response to topical steroids in children.

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.