NCT06819046已完成不适用
Improved Efficacy of Selective Laser Trabeculoplasty With the Addition of Rocklatan Post-treatment vs Artificial Tears Post-treatment
Colorado Ophthalmology Associates PC1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2025年2月14日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Mean diurnal IOP
研究概览
简要总结
A randomized, single-site, parallel-group, prospective study of patients who are candidates for SLT, to study the effect of IOP change with Rocklatan vs artificial tears.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18 years and older
- •Documented diagnosis of mild to moderate primary open angle glaucoma or ocular hypertension. Diagnosis of primary open angle glaucoma must be supported by the following:
- •24-2 SITA faster within the last 6 months
- •- With a mean deviation of 0 to -12 dB, excluding patients that meet severe criteria by having defects involving fixation or in two hemispheres.
- •OCT RNFL and optic nerve examination within the last 6 months
- •Diffuse or focal narrowing or notching of the optic disc rim, progressive narrowing of the neuroretinal rim, diffuse or localized thinning of the parapapillary RNFL, optic disc asymmetry of the two eyes consistent with loss of neural tissue, or thinning of the RNFL/GCA on examination or imaging
- •Progressive thinning on SD-OCT of 7 microns in inferior and superior quadrants or >4 micron loss in global RNFL thickness
- •Deviation from this ISNT rule (inferior, superior, nasal and temporal order of RNFL thickness with the inferior RNFL quadrant being the thickness)
- •Candidate for bilateral SLT
- •Post-washout, post-SLT IOPs between 28-10
- •Gonioscopy findings of Schafer grade III and IV
排除标准
- •Patients MD <-12, HVF defects in both hemispheres or involving fixation
- •Medication conditions that prevent SLT
- •Prior use of rho kinase inhibitor
- •Previous SLT performed on either eye
- •Prior MIGS implanted in either eye
- •Prior or current intolerance of a Rho kinase inhibitor
- •Uncontrolled IOP on maximum tolerated medical therapy; unable to washout
- •Narrow angles or other angle abnormalities
- •History of corneal disease or dystrophy, including endothelial dysfunction
- •History of corneal edema
- •Current or history of intra-ocular infection or inflammation
- •History of retinal diseases that will could affect diagnostic testing
- •Anticipated use of intra-ocular or topical steroids not associated with the study protocol
- •Current participation of study drugs or devices or within 6 months prior to screening
- •Pregnant or planning to be pregnant throughout the study
- •Any condition in the opinion in the investigator that would potentially confound the results of this study
研究组 & 干预措施
Rocklatan
netarsudil and latanoprost ophthalmic solution 0.02%/0.005%
干预措施: Rocklatan (Drug)
Systane Ultra
artificial tears
干预措施: Systane Ultra (Drug)
结局指标
主要结局
Mean diurnal IOP
时间窗: 6 weeks of treatment
次要结局
- Change in mean diurnal IOP from baseline(28 days of treatment)
研究者
研究点 (1)
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