Prospective Evaluation of the New Micropulse Transscleral Cyclophotocoagulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Intraocular pressure-lowering effect
研究概览
简要总结
The purpose of this study is to investigate the surgical outcomes of the micropulse transscleral cyclophotocoagulation (mTSCPC) in patients with uncontrolled glaucoma; analyze intraocular pressure lowering effect; and correlate related treatment parameters pending enrollment of sufficient numbers of dark pigmented versus light pigmented eyes.
详细描述
If the subject agrees to participate in this study, he/she will come in for a screening visit to make sure they qualify for the study. Following the surgical procedure, principal investigator will perform a standard postoperative examination at Day 1, Week 1, Month
1, Month 3, Month 6 and Month 12, in addition to any other visits the investigator feels may be necessary.
Screening Visit: At the screening visit, the subjects medical history and current medications will be reviewed. Pre-operative eye pressure and visual acuity will be noted. The Kowa Flare Meter-500 laser flare meter and slit lamp (the table-top microscope used for examining the eye) will be used to measure inflammation in subjects anterior chamber (the fluid-filled space between the iris (colored part of the eye) and cornea (clear front part of the eye that covers the iris and pupil).
Surgery: On the day of the subjects surgery, the subject will undergo the standard procedure for transscleral cyclophotocoagulation (TSCPC) laser surgery using the micropulse delivery mode of diode laser. After the Principal investigator finishes with the laser, he/she will perform anterior chamber paracentesis, which will help reduce the pressure in the subjects eye quickly and temporarily. To do this, the principal investigator will puncture the cornea (the clear front part of the eye that transmits and focuses light into the eye) to remove some of the aqueous (fluid inside the eye). Paracentesis is usually not done if TSCPC is performed using the "continuous" delivery mode.
Post-Operative Exams: At each of the post-operative office visits (Day 1, Week 1, Months 1, 3, 6 and 12) a detailed medical/eye history will be taken, including all current medications, vision will be tested and an eye examination will be performed, including measurement of eye pressure. Subject will be asked about his/her comfort level in regards to pain. At visit Day 1 and Month 1 the amount of anterior chamber inflammation will again be measured (as described in Screening Visit).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a minimum of 6 months follow-up with uncontrolled glaucoma as defined by:
- •Progression and/or intraocular pressure above target despite maximal tolerated medical therapy
- •Evidence of glaucomatous optic nerve damage and glaucomatous visual field loss in at least one hemifield
排除标准
- •Age ≤ 20 years old.
- •Patients who had undergone previous intraocular surgery or ocular laser treatment within 2 months of enrolment.
- •Patients who had undergone previous conventional continuous wave mode TSCPC within 1 months of enrolment.
- •Patients with significant scleral thinning as defined by greater than 1 clock hour.
- •Patients with any medical condition that would preclude the subject from providing informed consent or reliable and valid data.
- •Patients enrolled in other prospective clinical trials.
- •Albino patients that have no pigmentation
研究组 & 干预措施
Transscleral Cyclophotocoagulation
Subjects undergo a Micropulse Transscleral Cyclophotocoagulation(TSCPC) laser surgery, where a diode laser is used to damage tissue of the ciliary body, the tissue inside the eye that produces aqueous, the clear fluid in the eye that maintains intraocular pressure. This causes it to produce less aqueous.
干预措施: Micropulse Transscleral Cyclophotocoagulation (Procedure)
结局指标
主要结局
Intraocular pressure-lowering effect
时间窗: 2 years
The primary outcome measure will be treatment success, defined by an intraocular pressure (IOP) between 5 and 21mmHg (millimeters of mercury) or a 20% reduction from baseline with or without the addition of anti-glaucoma medications. Within the success group there will be sub-categories of ''qualified success" defined as achieving target IOP with the aid of anti-glaucoma medications.
次要结局
未报告次要终点
研究者
Marlene Moster, MD
Principal Investigator
Wills Eye