CTRI/2024/04/066490尚未招募4 期
The effect of additional versus no preoperative topical steroids on trabeculectomy outcomes in Indian eyes- a randomized control trial
Medical research foundation, Sankara Nethralaya1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年5月11日最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Complete success- IOP of greater than or equal to 6mmHg or less than or equal to 18 mmHg on Goldmann applanation tonometry, without the need for additional medication or procedure for IOP control, or vision threatening complications (endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etc)
研究概览
简要总结
| This |
| study is a randomized, outcome assessor blinded, parallel group, |
| single-centre trial comparing efficacy of preoperative topical steroid drops |
| (prednisolone acetate 1% or Fluorometholone 0.1%) versus no preoperative |
| topical steroids in primary glaucoma patients planned for surgery. Outcome |
| will be primarily assessed in terms of complete success. |
| Additionally, the qualified success, failure rates, inflammatory markers (for a subset), bleb |
| characteristics in these three groups will also be compared |
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Primary glaucoma on topical IOP lowering medication for at least 6 months Glaucoma not controlled on medical therapy Patient intolerant to topical IOP lowering medication for IOP control Glaucoma controlled on medical therapy but patient with more than two IOP lowering medication undergoing cataract surgery Age atleast eighteen years or older Snellen best corrected visual acuity of 6/60 or better.
排除标准
- •Any patient with uncontrolled IOP and glaucomatous damage requiring surgical intervention at the earliest and hence unable to take the preoperative topical steroid course Active severe inflammation requiring topical steroids within the last 3 months History of Yttrium Aluminum Garnet peripheral iridotomy (YAG PI) within the last 3 months Those with history of laser trabeculoplasty Prior surgery other than uncomplicated clear corneal phacoemulsification Other ocular pathology including retinal pathology, uveitis Secondary glaucoma including but not limited to steroid induced glaucoma, ICE syndrome, pseudoexfoliation glaucoma, pigment dispersion syndrome, neovascular glaucoma History of ocular trauma in the eye planned for trabeculectomy Myopia more than 6D/ pathological myopia One eyed patients Pregnant or nursing women Concurrent or steroid use within last 3months for other diseases.
结局指标
主要结局
Complete success- IOP of greater than or equal to 6mmHg or less than or equal to 18 mmHg on Goldmann applanation tonometry, without the need for additional medication or procedure for IOP control, or vision threatening complications (endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etc)
时间窗: 6 weeks, 4-5 months and 10-12 months post surgery
次要结局
- Qualitative and quantitative assessment of ocular fluid and tissue for inflammatory markers among the three groups (in a subset)(At enrollment(tear sample) and on day of surgery (ocular fluid and tissue))
- Qualified success: additionally includes those with the criteria for success but additionally includes those with IOP control obtained on use of on IOP lowering medication also(6 weeks, 4-5 months and 10-12 months)
- Number of medications used for IOP control(6 weeks, 4-5 months and 10-12 months post surgery)
- Atleast 3 point total difference on bleb assessment of photograph(6 weeks, 4-5 months and 10-12 months post surgery)
- Failure defined as IOP of less than 6 or greater than 18 mmHg on Goldmann applanation tonometry, need for additional procedure for IOP control, or vision threatening complications like endophthalmitis, retinal detachment, large choroidal detachments, choroidal hemorrhage etc(6 weeks, 4-5 months and 10-12 months post surgery)
研究者
Parivadhini Annadurai
Medical research foundation, Sankara Nethralaya
研究点 (1)
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