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Background: Although the overall safety and tolerability of prostaglandin analogs (PGAs) are considered to be excellent, increased iris pigmentation has been reported. There is little published evidences show the incidence of iris color change after treatment with PGAs in Chinese population. Objective: The purpose of this clinical trial was to investigate the incidence of iris color change after the topical use of travoprost. Methods: A prospective observational observer-masked study was designed. A total of 73 eyes of 37 patients with primary open-angle glaucoma were enrolled in this trial. Travoprost eye drops (0.004%) was topically used once per night for 3 months. Forty-two normal eyes of 21 Chinese normal volunteers served as controls. All the eyes in this study had the iris of pure brown colour. Iris photographs were taken using a slit-lamp biomicroscope with an attached digital camera before trial and 3 months after trial respectively. The alteration of iris pigmentation was identified by five specialists in glaucoma independently through reading the series of photographs, and the same opinion from 3 specialists was accepted as the basis of iris pigmentation alteration as follows: darkening, non-certainty, unchanged. Iris color value of each iris picture was calculated with Picture Color Analyzer. Written informed content was obtained from the subjects before the medical work. Results: Under the observation of naked eyes, 26 eyes (35.6%) in trial group developed the increase of iris pigmentation after administration of travoprost, but no increase of iris pigmentation was found in normal control group. A significant difference was seen in the eye numbers of darkening, non-certainty and unchanged of color between trial group and control group ((chi)(2) = 21.467, P = 0.000). The color value of iris was insignificantly different at pre-treated duration or post-treated duration between trial group and control group (t = 1.048, P = 0.298; t = -0.323 , P = 0.747). Seventeen eyes (23.3%) in trial group were determined as the darkening color in iris after use of travoprost by both the naked eye and computer; 22 eyes (30.1%) were decided the darkening color in iris by only computer and 26 eyes (35.6%) by only naked eye. Conclusion: These outcomes indicate that iris hyperpigmentation occur in about 35.6% eyes of Chinese patients in three months after administration of travoprost.
P. Huang. Department of Ophthalmology, Peking University Third Hospital, Peking University Eye Center, Beijing 100191, China. wllc@mail.hz.zj.cn
11.4 Prostaglandins (Part of: 11 Medical treatment)
2.8 Iris (Part of: 2 Anatomical structures in glaucoma)