Comparison of the effect of 40% autologous serum drop with artificial tear drop in improving corneal epithelial injury after corneal collagen cross-linking surgery, epithelium-off: a double-blind randomized controlled trial

Abstract

Corneal epithelium-off collagen cross-link surgery is a technique that is done by removing the corneal epithelium. It has better efficiency and performance compared to epithelium-on procedures in terms of stopping the progression of keratoconus. However, the healing of epithelial damage also requires time, and during this time, patients experience and tolerate pain in different areas of the surgical site. The aim of the current study is to compare the results of using 40% autologous serum eye drops compared to the artificial tear drop group after corneal epithelium-off collagen cross-link surgery. Materials and Methods: In this double-blind, single-center randomized clinical trial, patients with keratoconus who are ready for surgery were included in the study. Patients were randomly divided into two intervention groups (40% autologous serum drop) and control group (artificial tear drop) using computer software. First, the patients underwent a complete ophthalmological examination. Before surgery, complete medical history, complete ophthalmological examination, uncorrected and corrected visual acuity, refraction before and after cycloplegia, ophthalmoscopic tonometry, topography, recorded pachymetry and patients with corneal thickness less than 400 microns, history of ocular herpes, Recent history of any type of eye infection, presence of corneal scarring or opacity, neurotrophic keratopathy, positive history of autoimmune diseases and pregnancy were excluded from the study. Results: 34 patients (34 eyes) after corneal epithelium-off corneal collagen cross-linking surgery were investigated in terms of improvement of corneal epithelial damage in two intervention groups (autologous serum 40% with artificial tears) and control group (artificial tears). were placed The average age of the patients was 23.76 ± 3.87 years with a range of 18 to 30 years. 64.7% (22 cases) of patients were female and 35.3% (12 cases) were male. In the evaluation of CED, in the patients of the intervention group, on the day after the operation, 7 cases (42.2%) of the patients did not have CED, and in the rest of the patients, only a few areas of PEE were observed in the center of the cornea, and in these patients, the recovery was achieved on the third day after the operation. Pain intensity was significantly lower in the intervention group than in the control group (1.82 vs. 4.88; p=0.001). The two groups did not have statistically significant differences in terms of mood and sleep. Regarding the adverse effect after surgery on studying and using computers, driving and watching TV, no statistically significant difference was observed between the two groups; But significantly, the adverse effect after surgery was more in patients of the control group than in the intervention group. In comparing the improvement of eye pain compared to the previous visits, it was observed in the final visit that the improvement rate in the intervention group was 74.70 ± 5.82% and in the control group it was 38.82 ± 4.91%, which is a statistically significant difference was also observed between the two groups (p=0.001).