A prospective study on ocular hypertensive and antiinflammatory response to different dosages of fluorometholone in children

Objective; To investigate the ocular hypertensive and anti inflammatory res ponse to different dosages of fluorometholone (FML). Design: Prospective clinical trial with randomization of fellow eyes to dif ferent postoperative treatment. Participants: Thirty-one consecutive children undergoing bilateral symmetri cal strabismus operation. Intervention: Among 31 children who received bilateral squint operations, o ne eye was randomized to receive topical FML six times daily (group 1), whe reas the other eye received topical FML three times daily (group 2), both f or 4 weeks. Intraocular pressure (IOP) and antiinflammatory response were m easured 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 anti inflammatory response was also assessed subjectively and objectively at da ys 6, 13, 20, and 27 after the operations. Peak IOP, net increase in IOP, a nd anti inflammatory responses in the two study groups were analyzed. Results: Thirty-one children, age 3 to 9 years, (mean +/- standard deviatio n [SD], 5.52 +/-1.81) participated in the study. Intraocular pressure incre ased 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 mmH g in groups 1 and 2, respectively. The mean peak IOP (19.00<plus/minus>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 <plus/minus> SD, 4.37 +/-4.79 v s. 2.57 +/-3.32 mmHg; P=0.005). Ranges of the net IOP increase were -1.00 t o 16.00 mmHg and -2.50 to 10.30 mmHg in groups 1 and 2, respectively. Child ren 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 an ti inflammatory response between the two groups. Conclusions: Ocular hypertension occurs in a dose-dependent manner in child ren treated with FML. Children in group I had a quicker onset and more seve re ocular hypertensive response than those in group 2. It would be desirabl e to monitor the IOP regularly when FML is used with a high frequency and f or a long duration in children. Ophthalmology 2001;108:1973-1977 (C) 2001 b y the American Academy of Ophthalmology.