An Observational Prospective Longitudinal Study for the Clinical Evaluation of Visual Field Change in Glaucoma. An Assessment of Different Models of Progression
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).
研究概览
简要总结
The purpose of this observational study is to collect over time a series of data in patients with glaucoma in order to evaluate different approaches in defining the progression of this pathology. These data will be collected in repeated visits over a 36-months follow-up period. At each visit, the COMPASS fundus perimeter and the Humphrey Field Analyzer (HFA) perimeter will be used to assess retinal functionality; an Optical Coherence Tomography (OCT) examination will also be performed to evaluate and obtain clinical information about the structure of the retina.
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
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Glaucomatous optic nerve head in both eyes;
- •Age between 40 and 90 years;
- •Best Corrected Visual Acuity ≤ 0.3 [logMar];
- •Spherical refraction between -6D and +6D;
- •Astigmatism between -2D and +2D.
排除标准
- •Any ocular surgery, except for: uncomplicated cataract surgery and/or glaucoma surgery in both eyes performed within 6 months before enrollment;
- •Any ocular pathology that can affect visual field other than glaucoma;
- •Use of any drug that can interfere with the correct execution of perimetry or that would produce visual field loss;
- •Inability to obtain reliable perimetric examinations;
- •Patients with advanced glaucoma for whom, according to the clinician, a 24-2 grid is not advisable to correctly monitor the patient.
结局指标
主要结局
Equivalence between Compass and HFA in terms of estimation of the global progression rate (MD progression slope).
时间窗: 1 visit every 4 months (10 visits total), up to 3 years
Equivalence will be defined as the 95% confidence Intervals of the mean difference between the slopes estimated with the two devices being within ± 0.1 dB/year
次要结局
- Quantification of the effect of the integration of the rate of progression of structural metrics into the calculation of the rate of progression of the MD(1 visit every 4 months (10 visits total), up to 3 years)
- Difference in time to identify progression between Compass and HFA using an event analysis(1 visit every 4 months (10 visits total), up to 3 years)