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临床试验/ISRCTN13800424
ISRCTN13800424已完成未知

Clinical performance of Compass in the diagnosis of glaucoma: a comparison with Humphrey HFA.

CenterVue SpA0 个研究点目标入组 1,041 人开始时间: 2015年8月20日最近更新:
适应症

试验速览

阶段
未知
状态
已完成
发起方
CenterVue SpA
入组人数
1,041

研究概览

简要总结

2019 Results article in https://pubmed.ncbi.nlm.nih.gov/30114416/ results (added 01/09/2020) 2022 Results article in https://doi.org/10.3389/fmed.2022.923096 (added 12/09/2023) 2020 Results article in http://dx.doi.org/10.1136/bjophthalmol-2019-315070 (added 12/09/2023)

研究设计

研究类型
Observational

入排标准

性别
All

入选标准

  • Normal subjects:
  • 1. Age: 18 - 90 years old
  • 2. best corrected visual acuity > 0.8 (if <50 years old) or >6/10 (if >50 years old) in study eye
  • 3. Refraction -10D / +6D; astigmatism between - 2D and 2D
  • 4. Normal optic nerve head in both eyes (no evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning);
  • 5. IOP less than 21 mmHg in both eyes
  • 6. No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
  • 7. Absence of pathologies that can affect visual field
  • 8. No use of drugs interfering with the correct execution of perimetry
  • 9. Should have at least two reliable VF exams (for example one HFA, one Compass)
  • Glaucoma patients:
  • 1. Age: 18 - 90 years old
  • 2. Best corrected visual acuity > 0.8 (if <50 years old) or >6/10 (if >50 years old) in study eye;
  • 3. Refraction -10D / +6D; astigmatism between - 2D and 2D
  • 4. Glaucomatous optic nerve head in both eyes (according to the specialist opinion at ophthalmoscopy) and abnormal OCT (ONH and RNFL)
  • 5. Patients under anti-glaucoma therapy
  • 6. No ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
  • 7. Absence of pathologies that can affect visual field other than glaucoma
  • 8. No use of drugs interfering with the correct execution of perimetry or that would produce visual field loss
  • 9. Should have at least two reliable VF exams (for example one HFA, one Compass)

排除标准

  • Normal subjects:
  • 1. Age: <18 or >90 years old
  • 2. Best corrected visual acuity <= 0.8 (if <50 years old) or <=6/10 (if >50 years old) in study eye
  • 3. Refraction < -10D or >+6D; astigmatism between <- 2D or >2D
  • 4. Abnormal optic nerve head in both eyes ( evidence of excavation, rim thinning, notching, disc hemorrhages, RNFL thinning)
  • 5. IOP > 21 mmHg in both eyes
  • 6. Ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
  • 7. Presence of pathologies that can affect visual field
  • 8. Use of drugs interfering with the correct execution of perimetry
  • 9. Less than two reliable VF exams
  • Glaucomatous subjects:
  • 1. Age: <18 or >90 years old
  • 2. Best corrected visual acuity <= 0.8 (if <50 years old) or <=6/10 (if >50 years old) in study eye
  • 3. Refraction < -10D or >+6D; astigmatism between <- 2D or >2D
  • 4. Normal optic nerve head in both eyes (according to the specialist opinion at ophthalmoscopy) and normal OCT (ONH and RNFL)
  • 5. Patient not under anti-glaucoma therapy
  • 6. Ocular pathologies, trauma, surgeries (apart from uncomplicated cataract surgery) in both eyes
  • 7. Presence of pathologies that can affect visual field other than glaucoma
  • 8. Use of drugs interfering with the correct execution of perimetry or that would produce visual field loss
  • 9. Less than two reliable VF exams (for example one HFA, one Compass)

研究者

发起方
CenterVue SpA

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