10-year Follow up of Patients With Pigment Dispersion Syndrome: Risk Factors for Conversion to Pigmentary Glaucoma and Potential Protective Effect of a Yag-laser Iridotomy in High Risk Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 2
- 主要终点
- > 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)
研究概览
简要总结
STUDY AIMS
- To determine the 10-year conversion rate from pigment dispersion syndrome (PDS) to pigmentary glaucoma (PG)
- To evaluate the possible protective effect of a Yag-laser iridotomy
详细描述
1154 workers in the Parma area will be screened for eligibility to long-term use of video-monitors. Those referred to the Glaucoma Clinic for suspected PDS will be enrolled in the study.
In a prospective study on the natural history of PDS and PG, Richter et al. (Arch Ophtal 104:211-5, 1986) found an association between "active pigment dispersion" and elevated IOP. Therefore, in order to evaluate the "stability" of the pigment, a phenylephrine test will be performed following the method reported by Epstein et al (1978) AJO 85:43-50. The test will be performed by one investigator (SAG)and was considered positive if > "grade 1+" (i.e. at least 10 particles in a single light beam). Eyes showing a positive test will be considered as "high-risk" for conversion to PG.
Yag laser iridotomy will be performed in patients showing both eyes at high risk. One eye only (randomly chosen) will be treated. the fellow eye will be left untreated and considered as internal control.
Low risk eyes will be followed without any intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Krukenberg spindle
- •Slit-like mid peripheral iris defect
- •Pigment in > 270° of AC angle
排除标准
- •IOP > 18 mmHg
- •PEX (full mydriasis)
- •w/w field defect (Octopus G1 program)
结局指标
主要结局
> 5 mmHg IOP increase vs baseline (average 2 highest readings, 8 am - 6 pm phasing, 6 readings)
时间窗: 10 years
次要结局
未报告次要终点
