CTRI/2019/12/022443进行中（未招募）1 期
A PROSPECTIVE TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THE g-STEAM (SCLERAL TRANSLOCATION ELASTO-MODULATION) PROCEDURE FOR THE TREATMENT OF PRIMARY GLAUCOMA IN INDIAN ADULTS
ALeyeGN Technologies LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •First Phase:
- •1. Male and female subjects are eligible for the study if they are 18 years old or older and have given written informed consent
- •2. Low visual potential BCDVA < 2/60
- •3. Having primary or secondary glaucoma with no or low visual potential and high IOP / or on treatment for the same
- •Second Phase:
- •1. Male and female subjects are eligible for the study if they are 18 years old or older and 80 years old or less and have given informed consent
- •2. Subject with OHT or POAG with IOP 18- 35 mmHg
- •3. May include PACG after YAG PI (Iridotomy patency and location documented) and requiring medical management.
- •4. Requiring one or more anti-glaucoma medication for IOP control
- •5. Noncompliance, poor control or intolerability/allergy to topical hypotensive treatments
- •6. Diagnosis of glaucoma based on findings of
- •i. Glaucomatous optic neuropathy (GON)
- •ii. Field defects typical of glaucoma in a reliable visual field and/or OCT for retinal nerve fiber layer (RNFL) thinning IOP and gonioscopy
排除标准
- •First Phase:
- •1. Patients younger than 18 years or older than 80 years
- •2. Sighted patients BCDVA >2/60
- •3. Known allergy to involved topical medications
- •4. Severe systemic disease (i.e. uncontrolled diabetes mellitus, unstable collagen vascular diseases, etc.)
- •5. Disabling physical conditions
- •6. Pregnant or nursing women
- •7. Unable to return for scheduled follow-up visits
- •8. Unable to understand protocol
- •Second Phase
- •1. Patients younger than 18 years or older than 80 years
- •2. Advanced glaucoma with threat of loss of central visual fixation on perimetry
- •3. History of previous laser trabeculoplasty (LT) in the study eye
- •4. Severe eye trauma or uveitis
- •5. Inflammatory Peripheral anterior synechiae (PAS)
- •6. Use of systemic / topical steroids within the previous 3 months
- •7. Ocular surgery of any type within the previous 6 months
- •8. Trabeculectomy or glaucoma shunt surgery anytime
- •9. Media opacities interfering with gonioscopic or optic nerve evaluations
- •10. Best corrected distance visual acuity (BCDVA) of 20/200 or worse in the fellow eye
- •11. Central retinal vein occlusion (CRVO), branch vein occlusion (BRVO), or central retinal artery occlusion (CRAO), proliferative Diabetic retinopathy, uveitis, retinal degeneration in the fellow eye and/or study eye.
- •12. Known allergy to involved topical medications
- •13. Severe systemic disease (i.e. diabetes mellitus, collagen vascular diseases, etc.)
- •14. Disabling physical conditions
- •15. Pregnant or nursing women
- •16. Unable to return for scheduled follow-up visits
- •17. Unable to understand protocol
- •18. Secondary glaucoma
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