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临床试验/DRKS00029129
DRKS00029129
招募中
未知

Transorbital electrical stimulation as a vision restoration tool in patients with significant optic atrophy due to primary open-angle glaucoma. Acronym: VIROA (Vision Restoration in Optic Atrophy) - VIRON (Vision Restoration in Optic Neuropathy)

niversitätsmedizin Göttingen0 个研究点目标入组 300 人2022年11月10日

概览

阶段
未知
干预措施
未指定
疾病 / 适应症
H40.1
发起方
niversitätsmedizin Göttingen
入组人数
300
状态
招募中
最后更新
去年

概览

简要总结

暂无简介。

注册库
who.int
开始日期
2022年11月10日
结束日期
待定
最后更新
去年
研究类型
Interventional
性别
All

研究者

发起方
niversitätsmedizin Göttingen

入排标准

入选标准

  • Patients with diagnosis of primary open\-angle glaucoma (according to the EGS criteria), glaucomatous optic atrophy and significant visual field impairment typical for glaucoma (mean defect \>5dB)
  • \- Age \>/\= 40 years
  • \- Typical glaucomatous optic disc damage and visual field loss in one eye and either visual field loss or typical glaucomatous optic disc damage or both in the other eye
  • \- Familiarity with static perimetry (at least 5 examinations before starting this study)
  • \- Intraocular pressure \<22 mmHg (topically treated or untreated)
  • \- signed informed consent and willingness to participate

排除标准

  • \- any other type of glaucoma except POWG
  • \- Age \> 80 years
  • \- Visual field defect (mean defect) \>/\= 22dB or \<5dB
  • \- Visual acuity decimal \<0\.2
  • \- Deviation of the mean defect (MD) of \>2dB between screening (day \-28\) and the first initial examination (day \-21\)
  • \- Vision\-related affection of the refracting media (e.g., cataract or corneal scars) that would affect the assessment of study effects
  • \- other ophthalmological reasons for visual impairment (e.g. age\-related macular degeneration, diabetic retinopathy, optic atrophy of other origins apart from POAG, vascular occlusion)
  • \- any surgical procedure within 3 months prior to study entry
  • \- Status post glaucoma surgery or eye pressure\-reducing laser or cryotherapy within 3 months prior to study entry
  • \- Status post intraocular surgery within 6 months prior to study entry

结局指标

主要结局

未指定

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