CTRI/2021/12/038392Not Applicable4 期
Studying the Efficacy and Safety of Combined Moxifloxacin-Dexamethasone Ophthalmic Solution (Eye Drops) for Topical Prophylaxis in Cataract Surgery
Aristopharma Ltd0 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
- 4 期
- 状态
- Not Applicable
- 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
- •i. All patients with cataract who have consented for cataract surgery.
- •ii. Patients with controlled diabetes mellitus.
- •iii. Age: adult patients (above 18 years).
- •iv. Patients agree to participate in this study.
- •v. Patients who have no known hypersensitive reaction to moxifloxacin and dexamethasone.
- •vi. Patients are not using ocular antimicrobial drugs within 30 days of enrollment.
- •vii. Patients are not using topical or systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) and immunosuppressive therapy in the 14 days before enrollment.
- •vii. Patients are not suffering from any terminal illness.
- •viii. Patients have not proliferative diabetic retinopathy, or moderately severe non-proliferative diabetic retinopathy.
- •ix. Patients have not active inflammation on slit-lamp biomicroscopy or history of chronic or recurrent ocular inflammatory diseases (i.e., iritis, scleritis, uveitis, iridocyclitis, and rubeosis iridis), significant ocular pain and iris atrophy.
- •x. Patients with controlled glaucoma or ocular hypertension.
- •xi. Patients have not active epithelial herpes simplex, vaccinia, chicken pox, corneal or conjunctival disease, ocular tuberculosis or fungal disease.
- •xii. Patients have not any severe systemic disease or condition that made self-treatment with eye drops difficult.
- •xiii. Non-pregnant and non-lactating mothers.
- •xiv. Patients are not receiving a topical prostaglandin for IOP control within 4 days prior to surgery.
- •xv. Patients are not with complicated cataracts such as traumatic or subluxated.
- •xvi. Patients are not with severe thyroid disease.
排除标准
- •i. Patients with uncontrolled diabetes mellitus, proliferative diabetic retinopathy, or moderately severe non-proliferative diabetic retinopathy.
- •ii. Age: below 18 years.
- •iii. Patients are using topical or systemic steroids or nonsteroidal anti-inflammatory drugs (NSAIDs) and immunosuppressive therapy in the 14 days before enrollment.
- •iv. Patients are using ocular antimicrobial drugs within 30 days of enrollment.
- •v. Patients with active inflammation on slit-lamp biomicroscopy or history of chronic or recurrent ocular inflammatory diseases (i.e., iritis, scleritis, uveitis, iridocyclitis, and rubeosis iridis), significant ocular pain and iris atrophy.
- •vi. Patients with uncontrolled glaucoma or ocular hypertension.
- •vii. Patients who have known hypersensitive reaction to moxifloxacin and dexamethasone.
- •viii. Patients with active epithelial herpes simplex, vaccinia, chicken pox, corneal or conjunctival disease, ocular tuberculosis or fungal disease.
- •ix. Patients with any severe systemic disease or condition that made self-treatment with eye drops difficult.
- •x. Patients with sight in a single.
- •xi. Pregnant and lactating mothers.
- •xii. Patients are receiving a topical prostaglandin for IOP control within 4 days prior to surgery.
- •xiii. Patients with complicated cataracts such as traumatic or subluxated.
- •xiv. Patients will have combined operations with cataract surgery such as trabeculectomy or a corneal graft.
- •xv. Patients with severe thyroid disease.
- •xvi. Patients with open infection anywhere, infection of lacrimal drainage channels or infection around the eye.
- •xvii. Patients wearing contact lens during study.
- •xviii. Patients having secondary implantation or IOL replacement in the treated eye, or wore contact lenses.
- •xviii. Patients refuse to participate in the study.
研究者
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