| Objective:Designed a new procedure of corneal stroma injection—Tri-cyclic corneal stroma injection(TCSI)procedure.To evaluate the efficacy and safety of the novel TCSI voriconazole(0.5 mg/mL)for the treatment of fungal keratitis.Method:This retrospective cohort study included data of 57 patients(57 eyes)with fungal keratitis who were hospitalized in the Department of Ophthalmology,Qilu Hospital of Shandong University from February 2015 to December 2019.The TCSI group consisted of 27 patients(27 eyes)who were injected voriconazole via TCSI procedure within a week of enrolment,in addition to conventional anti-fungal treatment.The control group consisted of 30 patients(30 eyes)who were treated using conventional anti-fungal treatment modalities.The baseline data of the patients in two groups were collected,including age,gender,occupation,affected eye,whether there was systemic disease,whether there was a medical treatment before enrolment,the duration of symptoms,ulcer location,the size of the corneal infiltration/scar,the size of the corneal epithelial defect,the depth of infiltration,whether there was hypopyon,the best corrected visual acuity(BCVA)and the results of fungal culture.To evaluate the efficacy of TCSI voriconazole,we compared the BCVA of 3 weeks and 3 months after enrolment;the size of the comeal infiltration/scar of 3 weeks and 3 months after enrolment;the time of re-epithelialization;the risk of corneal perforation/therapeutic penetrating keratoplasty(TPK)required between the two group.To evaluate the safety of TCSI voriconazole,we compared the corneal endothelial cell density(ECD)before and after TCSI;intraocular pressure(IOP)of the injected eye and the contralateral eye before and after TCSI.Results:There were no significant differences in the baseline demographic and clinical characteristics between the two groups,including age,gender,occupation,affected eye,whether there was systemic disease,whether there was a medical treatment before enrolment,the duration of symptoms,ulcer location,the size of the corneal infiltration/scar,the size of the corneal epithelial defect,the depth of infiltration,whether there was hypopyon,BCVA and the results of fungal culture..After 3 weeks,the TCSI group exhibited a 0.13-LogMAR increase in visual acuity(95%CI,-0.40 to-0.05 LogMAR;P=0.01)and a 0.12-mm reduction in the size of the infiltration/scar(95%CI,-1.11 to 0.11mm;P=0.10)after controlling for baseline values.Three months after enrolment,the TCSI group exhibited an improvement of 0.16 LogMAR in visual acuity(95%CI,-0.49 to-0.07 LogMAR;P=0.01)and a 0.07-mm reduction in the size of the infiltration/scar(95%CI,0.86 to 0.35mm;P=0.40)after controlling for baseline values.The time to re-epithelialisation was 0.27 days shorter in the TCSI group than that in the control group(95%CI,-10.75 to-1.30d;P=0.01).Of all patients enrolled in this study,only two(4%)cases in the control group occurred corneal perforation and three(5%)cases received TPK(including the two cases who had corneal perforation).Although the risk of corneal perforation or TPK required in the TCSI group was lower than that of the control group after controlling for baseline corneal infiltrate depth,the difference was not statistically significant(odds ratio=0.002;95%CI,0 to 33.03;P=0.21).The corneas of 8 patients were relatively transparent and the ECD could be measured by In vivo confocal microcopy(IVCM).There was no significant difference between the corneal ECD on the day before and 7 days after TCSI at the same position[2231.33+/-649.02/mm2 before;2189.50+/-639.20/mm2(P=0.90)7 days after,respectively].5 patients had mild corneal edema,which IOP could be measured by a non-contact tonometer.There was no statistically significant difference between the mean pre-operative IOP and 1 day,3 day,7 day and 1 month post-TCSI IOP of the treated and the contralateral healthy eyes[15.18+/-2.72,14.2+/-3.06,14.34+/-3.11,14.04+/-3.14 and 15.60+/-2.89mmHg in treated eye,and 14.82+/-2.76(P=0.84),15.18+/-2.60(P=0.60),13.80+/-3.01(P=0.79),13.94+/-2.70(P=0.96)and 15.50+/-2.62(P=0.96)mmHg in contralateral healthy eye,respectively].Conclusion:Localised injection of voriconazole(0.5 mg/mL)using TCSI may be a minimally invasive,safe and effective adjuvant treatment modality for fungal keratitis.On the one hand,the procedure can improve the prognostic visual acuity,shorten the course of the disease and the time of drug treatment of patients with fungal keratitis.On the other hand,the procedure is safe which would not increase the area of corneal scar,damage the corneal endothelial cell and affect the aqueous circulation.At the same time,the TCSI procedure can be promoted to other diseases requiring corneal stroma injection. |
PDF Full Text Request