OBJECTIVE: To investigate the ocular-hypertensive response to different dosages of topical dexamethasone eye drops in Chinese children. DESIGN: Prospective, randomized clinical trial. PARTICIPANTS: Thirty-one consecutive children undergoing bilateral strabismus surgery. INTERVENTION: Topical dexamethasone (0.1%) was administered to children undergoing bilateral strabismus surgery. They were all less than 10 years of age. One eye was randomized to receive a regimen of four times daily, and another received a twice daily regimen. Intraocular pressure (IOP) was serially measured in the postoperative period for 4 weeks or more. Topical steroids were discontinued if IOP was 30 mmHg or more. MAIN OUTCOME MEASURES: Intraocular pressure was measured on the day before the surgery, on postoperative days 1, 3, 5, 8, 12, 15, 22, 29, and 2 weeks thereafter until the IOP reached preoperative levels. Peak IOP, IOP net increase, and time to reach an IOP more than 20 mmHg in the two study groups were analyzed. RESULTS: A total of 31 patients (20 male, 11 female) were examined. The mean age was 5.8 +/- 2.0 years (range, 2-10 years). Preoperative IOP in groups treated twice daily and four times daily were similar. After topical dexamethasone treatment, both groups showed a significant rise in peak IOP compared with preoperative values (twice daily, 25.2 +/- 6.8 mmHg vs. 14.3 +/- 2.4 mmHg, P < 0.001; four times daily, 28.7 +/- 6.9 mmHg vs. 14.3 +/- 2.9 mmHg, P < 0.001). The peak IOP was significantly higher in the four times daily group (P < 0.001), as was the net increase in IOP (twice daily, 10.9 +/- 5.8 mmHg vs. four times daily, 14.5 +/- 6.4 mmHg; P < 0.001). There was no difference in time for both groups to achieve the peak IOP, but the time to exceed its upper normal value (20 mmHg) was shorter in the four times daily group (twice daily, 12.3 +/- 9.1 days vs. four times daily, 10.0 +/- 7.4 days; P < 0.05). CONCLUSIONS: In children treated with topical dexamethasone, ocular hypertension occurs in a dose-dependent manner. Children in the four times daily group had a quicker onset and more severe ocular hypertensive response than the twice daily group. Nevertheless, even the twice daily regimen produced significant IOP rise, suggesting that dexamethasone use in children should be avoided if possible, and it would be desirable to monitor the IOP twice weekly when it is administered to children.
RCT Entities:
OBJECTIVE: To investigate the ocular-hypertensive response to different dosages of topical dexamethasone eye drops in Chinese children. DESIGN: Prospective, randomized clinical trial. PARTICIPANTS: Thirty-one consecutive children undergoing bilateral strabismus surgery. INTERVENTION: Topical dexamethasone (0.1%) was administered to children undergoing bilateral strabismus surgery. They were all less than 10 years of age. One eye was randomized to receive a regimen of four times daily, and another received a twice daily regimen. Intraocular pressure (IOP) was serially measured in the postoperative period for 4 weeks or more. Topical steroids were discontinued if IOP was 30 mmHg or more. MAIN OUTCOME MEASURES: Intraocular pressure was measured on the day before the surgery, on postoperative days 1, 3, 5, 8, 12, 15, 22, 29, and 2 weeks thereafter until the IOP reached preoperative levels. Peak IOP, IOP net increase, and time to reach an IOP more than 20 mmHg in the two study groups were analyzed. RESULTS: A total of 31 patients (20 male, 11 female) were examined. The mean age was 5.8 +/- 2.0 years (range, 2-10 years). Preoperative IOP in groups treated twice daily and four times daily were similar. After topical dexamethasone treatment, both groups showed a significant rise in peak IOP compared with preoperative values (twice daily, 25.2 +/- 6.8 mmHg vs. 14.3 +/- 2.4 mmHg, P < 0.001; four times daily, 28.7 +/- 6.9 mmHg vs. 14.3 +/- 2.9 mmHg, P < 0.001). The peak IOP was significantly higher in the four times daily group (P < 0.001), as was the net increase in IOP (twice daily, 10.9 +/- 5.8 mmHg vs. four times daily, 14.5 +/- 6.4 mmHg; P < 0.001). There was no difference in time for both groups to achieve the peak IOP, but the time to exceed its upper normal value (20 mmHg) was shorter in the four times daily group (twice daily, 12.3 +/- 9.1 days vs. four times daily, 10.0 +/- 7.4 days; P < 0.05). CONCLUSIONS: In children treated with topical dexamethasone, ocular hypertension occurs in a dose-dependent manner. Children in the four times daily group had a quicker onset and more severe ocular hypertensive response than the twice daily group. Nevertheless, even the twice daily regimen produced significant IOP rise, suggesting that dexamethasone use in children should be avoided if possible, and it would be desirable to monitor the IOP twice weekly when it is administered to children.
Authors: Timothy L Comstock; Michael R Paterno; Kirk M Bateman; Heleen H Decory; Matthew Gearinger Journal: Paediatr Drugs Date: 2012-04-01 Impact factor: 3.022
Authors: H Nida Sen; Susan Vitale; Sapna S Gangaputra; Robert B Nussenblatt; Teresa L Liesegang; Grace A Levy-Clarke; James T Rosenbaum; Eric B Suhler; Jennifer E Thorne; C Stephen Foster; Douglas A Jabs; John H Kempen Journal: Ophthalmology Date: 2014-07-11 Impact factor: 12.079