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临床试验/JPRN-UMIN000021220
JPRN-UMIN000021220已完成2 期

Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity-better than 0.9 decimal visual acuity - Surgical Outcomes of Vitrectomy for Epiretinal Membrane with Good Visual Acuity

ihon University hospital0 个研究点目标入组 40 人开始时间: 2018年2月26日最近更新:
适应症

试验速览

阶段
2 期
状态
已完成
发起方
入组人数
40

研究概览

简要总结

[Purpose] To evaluate the efficacy of epiretinal membrane removal in patients with good visual acuity for improving visual function and quality of life (QOL). [Subjects and Methods] A prospective case study. 37 subjects with good visual acuity better than 0.9 (good group) was compared to 35 patients with visual acuity of 0.3 to 0.8 (moderate group) in 3-and 6-month data. Linear mixed-effect models were used for statistical analysis. The primary outcome was 6 months postoperative horizontal metamorphopsia (MH). Secondary outcomes are postoperative visual acuity, 1,3,6-months postoperative MH, vertical metamorphopsia (MV), aniseikonia, streopsis, and central foveal thickness. In the good group, QOL assessment using NEI VFQ 25 at 6 and 12 months was examined. [Results] In good group, MH was improved significantly from 0.84 to 0.44 degree at 3 months, 0.45 degree at 6 months and 0.36 degree at 12 months after surgery (P<0.0001, respectively), however there was no significant difference from the moderate VA group. There was no improvement in MV score at the final observation in both groups. LogMAR VA significantly improved from -0.09 preoperatively to -0.046 at 12 months in good group and was significantly better than moderate group. Preoperative vertical and horizontal aniseikonia score remained unchanged in good group at 6 months (P = 0.75, 0.71), while in moderate group, both vertical and horizontal aniseikonia score worsened(P = 0.01, 0.01). The NEI VFQ-25 score improved in good VA group by general health, general vision, mental health.

研究设计

研究类型
Interventional

入排标准

年龄范围
20years-old 至 ot applicable(—)
性别
All

入选标准

  • 未提供

排除标准

  • 1 Eyes performed vitrectomy before 2 Eyes which have other diseases such as inflammatory or vascular diseases

研究者

发起方
ihon University hospital

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