Objective: To investigate the ocular hypertensive and antiinflammatory response to different dosages of fluorometholone (FML).
Design: Prospective clinical trial with randomization of fellow eyes to different postoperative treatment.
Participants: Thirty-one consecutive children undergoing bilateral symmetrical strabismus operation.
Intervention: Among 31 children who received bilateral squint operations, one eye was randomized to receive topical FML six times daily (group 1), whereas the other eye received topical FML three times daily (group 2), both for 4 weeks. Intraocular pressure (IOP) and antiinflammatory response were measured serially in the postoperative period for 8 weeks.
Main outcome measures: Intraocular pressure was measured on the day before surgery and on postoperative days 1, 3, 6, 13, 20, 27, 41, and 55. The antiinflammatory response was also assessed subjectively and objectively at days 6, 13, 20, and 27 after the operations. Peak IOP, net increase in IOP, and antiinflammatory responses in the two study groups were analyzed.
Results: Thirty-one children, age 3 to 9 years, (mean +/- standard deviation [SD], 5.52 +/- 1.81) participated in the study. Intraocular pressure increased significantly in both groups compared with the preoperative values (P < 0.001). The peak IOP ranged from 12.00 to 31.00 mmHg and 12.30 to 25.00 mmHg in groups 1 and 2, respectively. The mean peak IOP (19.00 +/- 5.06 mmHg vs. 17.13 +/- 3.32 mmHg) was significantly higher in group 1 (P < 0.001). The net increase in IOP was similar (mean +/- SD, 4.37 +/- 4.79 vs. 2.57 +/- 3.32 mmHg; P = 0.005). Ranges of the net IOP increase were -1.00 to 16.00 mmHg and -2.50 to 10.30 mmHg in groups 1 and 2, respectively. Children in group 1 reached the peak IOP earlier than those in group 2 (median, 6 vs. 13 days; P = 0.033). However, there was no significant difference in antiinflammatory response between the two groups.
Conclusions: Ocular hypertension occurs in a dose-dependent manner in children treated with FML. Children in group 1 had a quicker onset and more severe ocular hypertensive response than those in group 2. It would be desirable to monitor the IOP regularly when FML is used with a high frequency and for a long duration in children.