A prospective study on ocular hypertensive and antiinflammatory response to different dosages of fluorometholone in children1☆
Presented in part as a poster at the annual meeting of the American Academy of Ophthalmology, Dallas, Texas, October 2000.
Received 13 December 2000; accepted 5 June 2001.
Abstract
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.
Manuscript no. 200871.
aDepartment of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, Kowloon, Hong Kong
bDepartment of Ophthalmology, Alice Ho Miu Ling Nethersole Hospital, Tai Po, N.T., Hong Kong
Correspondence and reprint requests to Dennis S. C. Lam, FRCS, FRCOphth, Department of Ophthalmology and Visual Sciences, The Chinese University of Hong Kong, Hong Kong Eye Hospital, 147K Argyle Street, Kowloon, Hong Kong
☆ Supported in part by the Action For Vision Eye Foundation, Hong Kong.
1 The authors have no proprietary interest in the products or devices mentioned herein.
ABSTRACT