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临床试验/IRCT2016081329326N1
IRCT2016081329326N1已完成2 期

Effect of continuation of prostaglandin analogue use on the incidence of Cystoid Macular Edema (CME) following uncomplicated cataract surgery in glaucoma patients

Tehran University of Medical Sciences0 个研究点目标入组 166 人开始时间: 待定最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
入组人数
166

研究概览

简要总结

Purpose To evaluate the effect of postoperative latanoprost administration on central macular thickness (CMT) after uneventful cataract surgery in glaucoma patients. Setting Farabi Eye Hospital, Tehran, Iran. Design Prospective randomized clinical trial. Methods In this single-masked trial, glaucoma patients treated with latanoprost who had no other risk factor for the development of pseudophakic macular edema were randomly allocated to continuation of latanoprost or discontinuation of the drop after uneventful cataract surgery. At baseline and postoperatively at 1 month and 3 months, patients had complete ocular examinations and CMT measurements using optical coherence tomography. The main outcome measure was the change in the CMT between baseline measurements and postoperative measurements at 1 month and 3 months. Results One hundred fifty-six eyes (latanoprost 76; discontinuation 80) finished the trial. There were no differences in baseline patient demographics or characteristics, including the CMT, between the two groups. There was transient increase in the mean CMT by 12 µm ± 49 (SD) in the latanoprost group at 1 month (P = .03); however, the value returned to baseline by 3 months (6 ± 55 µm; P = .27). The between-group difference in the mean change in the CMT from baseline was -3.1 µm (95% confidence interval [CI], -18.4 to 12.0; P = .68) after 1 month and -10.5 µm (95% CI, -26.6 to 5.5; P = .19) after 3 months; the differences were not significant. Conclusion Latanoprost administration after cataract surgery had no measurable effect on macular thickness.

研究设计

研究类型
Interventional

入排标准

年龄范围
18 years 至 no limit(—)
性别
All

入选标准

  • Glaucoma patients with 18 years old or more
  • Treating with topical latanoprost 0.005% eye drop at least for 6 months with or without other antiglaucoma topical agents
  • Who needed cataract surgery (phacoemulsification)

排除标准

  • History of any intraocular surgery, intravitreal injections, or retinal laser
  • History of trauma
  • Non-glaucomatous optic neuropathy
  • High myopia
  • History of diabetic retinopathy, any age-related macular degeneration (AMD), uveitis, retinal detachment (RD), epiretinal membrane (ERM), and retinal vascular disorders
  • An occurrence of CME in the fellow eye following previous cataract surgery
  • Recent history of NSAID therapy (topical or oral)
  • Any abnormality in fundus examination except for glaucomatous changes
  • Any abnormality in pre-operative macular OCT.

研究者

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