Authors: Yu Jing, Feng Jun, Jie Ying, Jin Tao, Li Siyuan, Zhu Lei
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To observe the clinical effect of the biological amniotic membrane transplantation combined with interferon α2b eye drops (interferon eye drops) in the treatment of primary pterygium.
A randomized controlled clinical trial was used, 49 patients (55 eyes) of primary pterygium were selected in Beijing Tongren eye center from June to December, 2018, and all the subjects finished the follow up on time.The patients were randomly divided into two groups by random number table method, with 25 eyes of 23 patients in the experimental group and 30 eyes of 26 patients in the control group.The experimental group was treated with pterygium resection combined with amniotic membrane transplantation and interferon eye drops, while the control group was treated with pterygium resection combined with conjunctival autograft transplantation.Meanwhile the experimental group was treated with interferon eye drops on the 3rd day after surgery for 3 months.Follow up was done on the 3rd day, 7th day, 1st month, 3rd month and half a year after the surgery.The best corrected visual acuity (BCVA), heal of corneal epithelial defect and pterygium recurrence rate were observed.Written informed consent was obtained from each subject prior to entering the study cohort.The study protocol was approved by the Ethics Committee of Beijing Tongren Hospital (No.TRECKY2018-043).
At 6 months after surgery, there was no significant difference in number of eyes with decrease, stable or increase of BCVA between the two groups (P=0.259); Cornea epithelium of one eye in each group was healed within 14 days, and the cornea epithelia were healed within 7 days in all rest cases of the two groups, and there was no significant difference in the healing time of corneal epithelium between the two groups (P=1.000); At 6 months after the surgery, there was no true recurrence in the two groups, and there was no significant difference between the two groups of grade 1, 2 and 3 patients with conjunctival hyperplasia (Z=0.461, P=0.497). There were three eyes (3/25, 12.0%) and two eyes (2/30, 6.7%) had fibrovascular tissue hyperplasia in the experimental group and control group, respectively, but fibrovasular tissue hyperplasia was only appeared at the junction of conjunctiva and graft, and did not reach the center of the and graft or the limbus of cornea.
Compared with the traditional conjunctival autograft transplantation, amniotic membrane transplantation combined with interferon eye drops has no higher recurrence rate for the treatment of primary pterygium, while it is getting less damage to the healthy conjunctival tissue.