A Sciscio1, A G Casswell. 1. Sussex Eye Hospital, Eastern Road, Brighton BN2 5BF, UK.
Abstract
AIM: To determine the efficacy of apraclonidine hydrochloride 1% in preventing intraocular pressure (IOP) spikes following idiopathic macular hole (IMH) surgery withplatelet adjunct and intraocular gas tamponade. METHODS: This is a prospective, double masked, randomised study to compare apraclonidine hydrochloride 1%, an alpha(2) agonist, with a placebo in the prevention of IOP rises following macular hole surgery. Each patient was randomly selected to receive either the study drug or the placebo; one drop was instilled in the conjunctival sac 2 hours preoperatively and on completion of the procedure. IOP was measured at baseline and at 1, 3, 6, 24, 48 hours, and 2 weeks postoperatively. Blood pressure and heart rate were also recorded at baseline and at 3 and 24 hours postoperatively. Macular hole repair surgery was performed as standardised in the unit with a vitrectomy, platelet concentrate, and complete fill of the vitreous cavity with perfluoropropane gas (C(3)F(8)) at a concentration of 16%. RESULTS:25 patients (26 eyes) were enrolled. 12 eyes received apraclonidine hydrochloride1% (mean age 70.7; range 62-78 years) and 14 eyes received theplacebo (mean age 70.0; range 57-81 years). At baseline evaluation the mean IOP was 15.6 mm Hg for the study group and 14.3 mm Hg for the placebo group. The mean postoperative IOP at 1 hour, 3 hours, 6 hours, and 24 hours was 10.6, 9.6, 8.2, and 14.0 mm Hg in the apraclonidine group. In the control group at the same time intervals the mean IOP was 23.4, 17.5, 19.2, and 24.7 mm Hg. These readings were statistically significant different: 1 hour (p=0.0001); 3 hours (p=0.0015); 6 hours (p<0.0001); and 24 hours (p=0.019), the readings at 48 hours and 2 weeks were not statistically significant different (p=0.15 and p=0.59). Only one of the patients in the study group had an IOP above 25 mm Hg at any time. In the control group an IOP above 25 mm Hg was found in seven patients (50%) at the 1 hour postoperative measurement. At 2 weeks the IOP was recorded below 25 mm Hg in all patients. No statistically significantly difference was noted between the two groups regarding the systolic or diastolic blood pressure values and the heart rate records. No local or systemic adverse reactions were observed. CONCLUSIONS:Apraclonidine hydrochloride 1% appears to be an efficacious and safe drug in the prophylaxis of early postoperative IOP elevations in patients undergoing macular hole surgery.
RCT Entities:
AIM: To determine the efficacy of apraclonidine hydrochloride 1% in preventing intraocular pressure (IOP) spikes following idiopathic macular hole (IMH) surgery with platelet adjunct and intraocular gas tamponade. METHODS: This is a prospective, double masked, randomised study to compare apraclonidine hydrochloride 1%, an alpha(2) agonist, with a placebo in the prevention of IOP rises following macular hole surgery. Each patient was randomly selected to receive either the study drug or the placebo; one drop was instilled in the conjunctival sac 2 hours preoperatively and on completion of the procedure. IOP was measured at baseline and at 1, 3, 6, 24, 48 hours, and 2 weeks postoperatively. Blood pressure and heart rate were also recorded at baseline and at 3 and 24 hours postoperatively. Macular hole repair surgery was performed as standardised in the unit with a vitrectomy, platelet concentrate, and complete fill of the vitreous cavity with perfluoropropane gas (C(3)F(8)) at a concentration of 16%. RESULTS: 25 patients (26 eyes) were enrolled. 12 eyes received apraclonidine hydrochloride 1% (mean age 70.7; range 62-78 years) and 14 eyes received the placebo (mean age 70.0; range 57-81 years). At baseline evaluation the mean IOP was 15.6 mm Hg for the study group and 14.3 mm Hg for the placebo group. The mean postoperative IOP at 1 hour, 3 hours, 6 hours, and 24 hours was 10.6, 9.6, 8.2, and 14.0 mm Hg in the apraclonidine group. In the control group at the same time intervals the mean IOP was 23.4, 17.5, 19.2, and 24.7 mm Hg. These readings were statistically significant different: 1 hour (p=0.0001); 3 hours (p=0.0015); 6 hours (p<0.0001); and 24 hours (p=0.019), the readings at 48 hours and 2 weeks were not statistically significant different (p=0.15 and p=0.59). Only one of the patients in the study group had an IOP above 25 mm Hg at any time. In the control group an IOP above 25 mm Hg was found in seven patients (50%) at the 1 hour postoperative measurement. At 2 weeks the IOP was recorded below 25 mm Hg in all patients. No statistically significantly difference was noted between the two groups regarding the systolic or diastolic blood pressure values and the heart rate records. No local or systemic adverse reactions were observed. CONCLUSIONS:Apraclonidine hydrochloride 1% appears to be an efficacious and safe drug in the prophylaxis of early postoperative IOP elevations in patients undergoing macular hole surgery.