PURPOSE: To evaluate the role of umbilical cord serum therapy in cases of acute ocular chemical burns. METHODS: In a double-blind prospective randomized controlled clinical study, 33 eyes of 32 patients with acute ocular chemical burns of grade III, IV, and V severity were randomized into three groups: umbilical cord serum (n = 12), autologous serum (n = 11), and artificial tears (0.5% HPMC+0.3% glycerin; n = 10). In addition, all eyes received standard medical therapy. The parameters evaluated were pain score, size, and area of epithelial defect, extent of limbal ischemia, corneal clarity, and symblepharon formation. The patients were followed up at day 1, 3, 7, 14, and 21 and at the end of months 1, 2, and 3. RESULTS:Mean time to complete epithelialization was 21.16 ± 26.81, 56.6 ± 35.5, and 40.13 ± 35.79 days in cord serum, autologous serum, and artificial tears groups respectively (P = 0.02). By day 21, the mean percentage decrease in epithelial defect diameter was 94.63 ± 11.99 with cord serum compared with 53.17 ± 34.81 and 64.22 ± 42.43 with autologous serum and artificial tears, respectively (P = 0.01). By month 3, the extent of limbal ischemia with cord serum showed a mean percentage decrease of 73.43 ± 25.51 compared with 35.64 ± 25.60 and 43.71 ± 28.71 with autologous serum and artificial tears, respectively (P = 0.008). More patients had clear corneas with cord serum compared with autologous serum and artificial tears (P = 0.048). No significant difference was seen between the groups with regard to symblepharon formation (P = 0.07). CONCLUSIONS:Umbilical cord serum therapy is more effective than autologous serum eye drops or artificial tears in ocular surface restoration after acute chemical injuries. (www.controlled-trials.com number, ISRCTN08131903.).
RCT Entities:
PURPOSE: To evaluate the role of umbilical cord serum therapy in cases of acute ocular chemical burns. METHODS: In a double-blind prospective randomized controlled clinical study, 33 eyes of 32 patients with acute ocular chemical burns of grade III, IV, and V severity were randomized into three groups: umbilical cord serum (n = 12), autologous serum (n = 11), and artificial tears (0.5% HPMC+0.3% glycerin; n = 10). In addition, all eyes received standard medical therapy. The parameters evaluated were pain score, size, and area of epithelial defect, extent of limbal ischemia, corneal clarity, and symblepharon formation. The patients were followed up at day 1, 3, 7, 14, and 21 and at the end of months 1, 2, and 3. RESULTS: Mean time to complete epithelialization was 21.16 ± 26.81, 56.6 ± 35.5, and 40.13 ± 35.79 days in cord serum, autologous serum, and artificial tears groups respectively (P = 0.02). By day 21, the mean percentage decrease in epithelial defect diameter was 94.63 ± 11.99 with cord serum compared with 53.17 ± 34.81 and 64.22 ± 42.43 with autologous serum and artificial tears, respectively (P = 0.01). By month 3, the extent of limbal ischemia with cord serum showed a mean percentage decrease of 73.43 ± 25.51 compared with 35.64 ± 25.60 and 43.71 ± 28.71 with autologous serum and artificial tears, respectively (P = 0.008). More patients had clear corneas with cord serum compared with autologous serum and artificial tears (P = 0.048). No significant difference was seen between the groups with regard to symblepharon formation (P = 0.07). CONCLUSIONS: Umbilical cord serum therapy is more effective than autologous serum eye drops or artificial tears in ocular surface restoration after acute chemical injuries. (www.controlled-trials.com number, ISRCTN08131903.).