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临床试验/NCT01279993
NCT01279993已完成3 期

Orthoptic Changes Following Photorefractive Keratectomy

Shahid Beheshti University of Medical Sciences1 个研究点 分布在 1 个国家开始时间: 2008年4月最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
试验地点
1
主要终点
orthoptic changes

研究概览

简要总结

Purpose: To detect orthoptic changes in patients undergoing photorefractive keratectomy (PRK). Method: This interventional case series was performed on 297 eyes of 150 patients who were candidates for PRK. Complete ophthalmic evaluations focusing on orthoptic examinations were performed before and 3 months after PRK. Results: Before PRK, two (1.3%) patients had esotropia that remained unchanged postoperatively. However, 3 (2%) patients had distance exotropia preoperatively which improved after PRK. Of 12 cases (8%) with preoperative exotropia at near, 3 (2%) cases became orthophoric. Six patients (4%) developed postoperative near exotropia. A significant reduction in means of convergence and divergence amplitudes (P<0.001) and a meaningful increase in mean of near point of convergence (NPC) (P<0.006) were noticed after PRK. A reduction of ≥10 PD in convergence amplitude and ≥5 PD in divergence amplitude were detected in 10 and 5 patients, respectively. Four patients had an preoperative NPC>10 cm which was not changed by the surgery. Out of 9 (6%) patients with baseline stereopsis >60 seconds of arc, 2 (1.33%) cases showed an improvement in stereopsis following PRK. None of the patients complained of postoperative diplopia. Conclusion: Eye deviation in patients undergoing PRK may improve or remain unchanged after operation and postoperative deviations can develop following this surgery. Diminishing of fusional amplitude and increasing of NPC as well as improving of stereopsis may also happen after PRK. Therefore, a preoperative orthoptic examination in patients with any concerning histories and/or motility issues on routine exam is recommended before performing PRK.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Supportive Care

入排标准

年龄范围
18 Years 至 59 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • >18 yrs / refractive errors / with consent

排除标准

  • < 18 / corneal opacity - keratoconus
  • Dry eye / diabetes / collages vacuolar disease

结局指标

主要结局

orthoptic changes

时间窗: before and after KRS

Prism / (deviation)

次要结局

  • VA , Streopsis , deviation , fusion , NPC(before and after KRS)

研究者

研究点 (1)

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