Trusopt and Cosopt; Ocular Perfusion Pressure and Blood Flow: New Long-term Prospective Data
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- 3-year Change in OA EDV
研究概览
简要总结
To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.
详细描述
To analyze Cosopt® in terms of its effects on ocular perfusion pressure and comprehensive ocular blood flow and in relation to visual field progression and optic nerve structural changes in an ongoing 3 year prospective study involving 120 patients with open angle glaucoma.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 30 years or older.
- •Diagnosis: confirmed open-angle glaucoma in at least one eye:
- •glaucomatous visual field loss on Humphrey 24-2 or 10-2 perimetry
- •glaucomatous optic disc cupping
- •agreement between two baseline exams for reliability
- •Best corrected visual acuity at least 20/60 in at least one eye.
- •Prior Humphrey visual fields demonstrate acceptable reliability standards.
排除标准
- •Extensive Humphrey visual field damage consisting of either a mean deviation (MD) < -15 decibels or a clinically determined threat to fixation in both hemifields.
- •Evidence of exfoliation or pigment dispersion.
- •History of acute angle-closure or a narrow, occludable anterior chamber angle by gonioscopy.
- •History of chronic or recurrent inflammatory eye diseases (e.g., scleritis, uveitis).
- •History or signs of intraocular trauma.
- •Severe or potentially progressive retinal disease such as retinal degeneration, diabetic retinopathy, and retinal detachment.
- •Any abnormality preventing reliable applanation tonometry.
- •Current use of any ophthalmic or systemic steroid which may interfere with this investigation.
- •Cataract surgery within the past year.
- •Resting pulse < 50 beats per minute.
- •Severe, unstable or uncontrolled cardiovascular, renal, or pulmonary disease.
研究组 & 干预措施
Glaucoma patients
Patients with Glaucoma
干预措施: (Cosopt®, prostaglandin) (Drug)
结局指标
主要结局
3-year Change in OA EDV
时间窗: Baseline and 36 month visits
Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
3-year Change in OA RI
时间窗: Baseline and 36 month visits
Measurement of change in ocular blood flow - ophthalmic artery resistance index
3-year Change in CRA PSV
时间窗: Baseline and 36 month visits
Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
3-year Change in CRA EDV
时间窗: Baseline and 36 month visits
Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
3-year Change in CRA RI
时间窗: Baseline and 36 month visits
Measurement of change in ocular blood flow - central retinal arteries resistance index
3-year Change in OPP
时间窗: Baseline and 36 month visits
Measurement of change in ocular perfusion pressure
6-month Change in Ophthalmic Artery (OA) Peak Systolic Velocity (PSV)
时间窗: Baseline and 6 month visits
Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
6-month Change inOphthalmic Artery (OA) End Diastolic Velocity (EDV)
时间窗: Baseline and 6 month visits
Measurement of change in ocular blood flow - ophthalmic artery end diastolic velocity
6-month Change in Ophthalmic Artery (OA) Vascular Resistance (RI)
时间窗: Baseline and 6 month visits
Measurement of change in ocular blood flow - ophthalmic artery resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.
6-month Change in Central Retinal Artery (CRA) Peak Systolic Velocity (PSV)
时间窗: Baseline and 6 month visits
Measurement of change in ocular blood flow - central retinal arteries peak systolic velocity
6-month Change in Central Retinal Artery (CRA) End Diastolic Velocity (EDV)
时间窗: Baseline and 6 month visits
Measurement of change in ocular blood flow - central retinal arteries end diastolic velocity
6-month Change in Central Retinal Artery (CRA) Vascular Resistance (RI)
时间窗: Baseline and 6 month visits
Measurement of change in ocular blood flow - central retinal arteries resistance index, this is a measure of the amount of resistance to blood flow within the selected blood vessel.
6-month Change in Ocular Perfusion Pressures (OPP)
时间窗: Baseline and 6 month visits
Measurement of change in ocular perfusion pressure, the pressure of blood flow to the eye minus the pressure of within the eye.
3-year Change in OA PSV
时间窗: Baseline and 36 month visits
Measurement of change in ocular blood flow - ophthalmic artery peak systolic velocity
次要结局
未报告次要终点