CTRI/2022/04/042105进行中（未招募）不适用
Comparative Analysis of Single Dose Intraoperative Sub-conjunctival Depot Steroid to Routine Topical Steroids and NSAIDS in phacoemulsification
Aravind Eye Care System AECS1 个研究点 分布在 1 个国家目标入组 402 人开始时间: 2022年2月5日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 402
- 试验地点
- 1
- 主要终点
- Visual outcome with refractive erros
研究概览
简要总结
| Cataract surgery is the most common ocular surgical procedure worldwide. Surgical outcomes have become more predictable due to the improvement in surgical techniques, instrumentation and intraocular lens (IOL) design. [1] However Postoperative inflammation & CME are the commonly encountered postoperative complications following uncomplicated cataract surgery. The conventional treatment strategy to counter postoperative inflammation has been the use of various corticosteroid formulations alone or in combination with non-steroidal anti-inflammatory drugs for 4 to 8 weeks. In general, topical therapy is associated with the well-recognized problems of patient compliance and a variable amount of physician or staff time needed for patient instruction.[2] It is also associated with other drawback like improper instillation leading to corneal abrasions.peri-operatively during cataract surgery eliminate the need for application of postoperative steroid eye drops, which requires compliance from the patients. [6-10]Various methods of steroid delivery have been described to improve the patient’s compliance. Sub–conjunctival or sub-tenon injection of depot corticosteroids is an established method for the treatment of various inflammatory eye diseases, with a good therapeutic response and ocular tolerance. [3-5] several studies show that sub-conjunctival steroids given |
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 40.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 40 to 75 years 2.Patients undergoing topical phacoemulsification with monofocal foldable IOL implantation 3.Senile cataract 4.Axial length of 20.5 to 25mm 5.Staying within 100 kms from base hospital and willing for all follow up visits.
排除标准
- •1.Age <40 years 2.Diabetes retinopathy 3.Advanced cataract (BCVA 3/60 or less) 4.NSIV, Posterior polar, subluxated , traumatic, complicated and developmental cataract 5.Pregnant and lactating women 6.Patients with mental illness 7.Non visualization of fundus 8.CDR of 0.7 & more 9.IOP of 21 & above 10.Known case of glaucoma diagnosed based on cup disc ratio, field defects, RNFL defects or raised IOP and on treatment for the same 11.Family history of glaucoma 12.H/O steroid responsiveness 13.On systemic steroids for asthma, rheumatoid arthritis or other illness or history of steroid use by any route in the prior 3 months 14.Corneal diseases 15.Prior incisional ocular surgery 16.Associated ocular comorbidity (ARMD, pseudo exfoliation, small pupil (5mm or less), floppy iris, corneal opacity, macular scar, epiretinal membrane, retinal detachment, uveitis, shallow anterior chamber) 17.Central macular thickness (CMT) >250 μ to rule out macular edema and pachychoroid 18.Subfoveal choroidal thickness (SFCT) >300 μ 19.Presence of pachyvessels on EDI (enhanced depth imaging) OCT 20.On alpha adrenergic blockers for benign prostatic hypertrophy 21.Any intraoperative complications (PCR , ZD , Nucleus drop, Vitreous loss, iris injury) 22.Axial length <20.5mm and > 25mm 23.Any intraoperative complications (PCR , ZD , Nucleus drop, Vitreous loss).
结局指标
主要结局
Visual outcome with refractive erros
时间窗: 12 months
次要结局
- 1) Macula thickness 2) Incidence of CME 3) On additional medication for raised IOP/ glaucoma due to steroids 4) On additional medication for break through iritis(12 months)
研究者
研究点 (1)
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