CTRI/2024/03/064598尚未招募不适用
Evaluating the effect of Dorzolamide vs Netarsudil in Preperimetric and Early Glaucoma- A Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Vessel Density(ONH AND MACULAR) USING OCTA
研究概览
简要总结
Neuroprotective therapy which delay neurodegeneration can be used to halt disease progression in patients of preperimetric/early glaucoma
Dorzolamide (1994) is known to improve microcirculation in the optic nerve head and thus have a role in neuroprotection.
Netarsudil (2018) is a newly launched drug in glaucoma armamentarium, which not only lowers IOP but also improves ocular blood flow and promotes RGC survival
Hence, we plan to compare the effect of Dorzolamide and Netarsudil on OCTA vessel density in preperimetric /early glaucoma patients.
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研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Preperimetric Glaucoma- Age over 40 years Open angle in gonioscopy Baseline IOP ≤ 25mmHg Best-corrected visual acuity 20/40 or better (refractive error ± 5.0D spherical; ± 3.0D cylinder) Abnormal circumpapillary RNFL thickness (cpRNFLT) in at least one quadrant on OCT scan A visual field within the normal limits of a glaucoma hemifield test, with pattern standard deviation (PSD) greater than 5%, confirmed in at least two examinations Early Glaucoma- BCVA 20/40 or more (refractive error ± 5.0D spherical; ± 3.0D cylinder) Open angles on gonioscopy Baseline IOP ≤ 25mmHg Features suggestive of glaucomatous optic neuropathy such as cup‑disc ratio >0.6 and any diffuse or focal neuroretinal rim thinning 2 consecutive abnormal visual field tests defined as PSD outside 95% normal confidence limits and a GHT classified as ‘‘outside normal limits’’ as defined by the Hodapp-Parrish-Anderson (HPA) criteria for early glaucoma.
排除标准
- •Patients with moderate or advanced glaucoma (MD worse than ‑6 dB) Patients with media opacity precluding good‑quality OCT scans such as corneal opacity, cataracts, etc.
- •History of intraocular diseases, complicated intraocular surgery, secondary glaucoma Age< 40 years Coexisting retinal disease (for example, diabetic retinopathy) Other diseases affecting visual field Patients on vasodilatory drugs such as Nitroglycerin.
结局指标
主要结局
Vessel Density(ONH AND MACULAR) USING OCTA
时间窗: Day 1, 4 months, 8 months, 12 months(if possible)
次要结局
- Macular Flow Index(Day 1, 4 months, 8 months, 12 months(if possible))
- pRNFL Thickness(Day 1, 4 months, 8 months, 12 months(if possible))
- Visual Field Changes(Day 1, 4 months, 8 months, 12 months(if possible))
- Flux index(Day 1, 4 months, 8 months, 12 months(if possible))
研究者
研究点 (1)
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