High-Dose Antioxidants for Central Serous Chorioretinopathy
High-Dose Antioxidants for Central Serous Chorioretinopathy
A total of 58 eyes in 58 patients were included in the study and were randomized equally with 29 eyes in each group. Seven eyes (12%) were lost to follow-up or did not have enough data for analysis at the 3 month (3 eyes in the study group and 4 eyes in the control group). A total of 51 eyes (88%) were included in the final analysis (Figure 2).
The mean age and duration of CSC before enrollment of both groups were 40.4 years and 15.4 days. Although the study group showed a lower mean onset duration time than the control group (13.2 vs 17.5 days), the p-value demonstrated no statistical difference (p = 0.09). The mean baseline VA, CMT as determined by OCT and follow-up time in both groups were 0.25, 516 microns and 8.6 months, respectively. Most of OCT findings in both groups showed subretinal fluid and/or intraretinal edema but very few cases had cystoid macular edema. The baseline fluorescein leakage pattern of most cases (52 eyes, 90%) was inkblot leakage and only 6 eyes (10%, 3 in each group) demonstrated a smokestack pattern. The baseline demographic data are summarized in Table 1 and show no statistical significance between any of the parameters for both groups.
At the end of the 3 month, all patients showed no significant side effects. The VA and CMT in both groups also showed no statistical differences (p = 1.0 and 0.25, Figure 3, 4). Regarding the secondary outcomes, the number of eyes with subretinal fluid at the 3 month was higher in the control group than the study group (Table 2). Moreover, the number of eyes that demonstrated fluorescein leakage at the end of the 3 month was also higher in the control group (10 eyes) than in the study group (3 eyes) (odds ratio, 0.19; 95% CI, 0.046-0.83; p = 0.027) (Table 2). These patients were the same group of the patients with subretinal fluid at the 3 month. These results imply that the study drug might affect the leakage activity more than the fluid (both intraretinal and subretinal) absorption by retinal pigment epithelium. With regards to the recurrent rate, 3 patients developed a recurrent attack: 1 eye in the study group and 2 eyes in the control group (p = 0.29). Two of them (one in each group) had received additional treatments at the end of the 5 and 8 month, whereas another one had spontaneous resolution of subretinal fluid without any treatment.
(Enlarge Image)
Figure 3.
The mean visual acuity (VA) at each follow-up time between the study and control group. Study group (group A): the group received antioxidant tablets, Control group (group B): the group received placebo tablets, VA = visual acuity, logMAR = logarithm of minimum angle of resolution.
(Enlarge Image)
Figure 4.
The mean central macular thickness (CMT) at each follow-up time between the study and control group. Study group (group A): the group received antioxidant tablets, Control group (group B): the group received placebo tablets, CMT = central macular thickness.
Because of the difference in leakage activities after 3 months of randomization, 4 patients in the study group and 11 patients in the control group were considered for additional laser treatment or PDT (including 2 recurrent cases). The p-value also demonstrated significance (odds ratio, 0.23; 95% CI, 0.061-0.872; p = 0.03) in terms of these additional treatments (Table 2). Thereafter, although the study showed no significance between the final VA and CMT as determined by OCT, the results showed that the patients who received high-dose antioxidants in the acute phase of the disease had less of a chance of having subretinal fluid and being treated by laser or PDT at the end of the 3 month.
Results
A total of 58 eyes in 58 patients were included in the study and were randomized equally with 29 eyes in each group. Seven eyes (12%) were lost to follow-up or did not have enough data for analysis at the 3 month (3 eyes in the study group and 4 eyes in the control group). A total of 51 eyes (88%) were included in the final analysis (Figure 2).
The mean age and duration of CSC before enrollment of both groups were 40.4 years and 15.4 days. Although the study group showed a lower mean onset duration time than the control group (13.2 vs 17.5 days), the p-value demonstrated no statistical difference (p = 0.09). The mean baseline VA, CMT as determined by OCT and follow-up time in both groups were 0.25, 516 microns and 8.6 months, respectively. Most of OCT findings in both groups showed subretinal fluid and/or intraretinal edema but very few cases had cystoid macular edema. The baseline fluorescein leakage pattern of most cases (52 eyes, 90%) was inkblot leakage and only 6 eyes (10%, 3 in each group) demonstrated a smokestack pattern. The baseline demographic data are summarized in Table 1 and show no statistical significance between any of the parameters for both groups.
At the end of the 3 month, all patients showed no significant side effects. The VA and CMT in both groups also showed no statistical differences (p = 1.0 and 0.25, Figure 3, 4). Regarding the secondary outcomes, the number of eyes with subretinal fluid at the 3 month was higher in the control group than the study group (Table 2). Moreover, the number of eyes that demonstrated fluorescein leakage at the end of the 3 month was also higher in the control group (10 eyes) than in the study group (3 eyes) (odds ratio, 0.19; 95% CI, 0.046-0.83; p = 0.027) (Table 2). These patients were the same group of the patients with subretinal fluid at the 3 month. These results imply that the study drug might affect the leakage activity more than the fluid (both intraretinal and subretinal) absorption by retinal pigment epithelium. With regards to the recurrent rate, 3 patients developed a recurrent attack: 1 eye in the study group and 2 eyes in the control group (p = 0.29). Two of them (one in each group) had received additional treatments at the end of the 5 and 8 month, whereas another one had spontaneous resolution of subretinal fluid without any treatment.
(Enlarge Image)
Figure 3.
The mean visual acuity (VA) at each follow-up time between the study and control group. Study group (group A): the group received antioxidant tablets, Control group (group B): the group received placebo tablets, VA = visual acuity, logMAR = logarithm of minimum angle of resolution.
(Enlarge Image)
Figure 4.
The mean central macular thickness (CMT) at each follow-up time between the study and control group. Study group (group A): the group received antioxidant tablets, Control group (group B): the group received placebo tablets, CMT = central macular thickness.
Because of the difference in leakage activities after 3 months of randomization, 4 patients in the study group and 11 patients in the control group were considered for additional laser treatment or PDT (including 2 recurrent cases). The p-value also demonstrated significance (odds ratio, 0.23; 95% CI, 0.061-0.872; p = 0.03) in terms of these additional treatments (Table 2). Thereafter, although the study showed no significance between the final VA and CMT as determined by OCT, the results showed that the patients who received high-dose antioxidants in the acute phase of the disease had less of a chance of having subretinal fluid and being treated by laser or PDT at the end of the 3 month.