A Randomized, Controlled Study to Evaluate the Safety and Effectiveness of Treatment
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Absence of anterior chamber cells
研究概览
简要总结
This is a randomized, controlled study to assess the safety and effectiveness of treatment with an intracanalicular dexamethasone (0.4mg) insert when utilized in conjunction with topical steroids as part of an extended taper steroid regimen following cataract surgery in patients with a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
详细描述
There will be approximately 40 eyes with two groups:
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
Both groups will receive topical Prolensa Qa.m. x 5 weeks and Moxifloxacin TID x 1 week, per investigators preferential treatment regimen.
Each subject's participation is expected to last for approximately 5 weeks and subjects will be required to complete six scheduled visits over the course of the study period: Baseline (Screening Visit Day -1), Operative Visit (Day 0), Day 1, Day 8 (insertion day), Day 14, and Day 37.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be eligible for study participation if they:
- •Are planning to undergo non-complicated CCI CE/PCIOL in one or both eyes and have a history of epiretinal membrane, diabetic retinopathy, or non-exudative macular degeneration.
- •Are willing and able to comply with clinic visits and study related procedures
- •Are willing and able to sign the informed consent form
- •Patients age 18yo+
排除标准
- •Subjects are not eligible for study participation if they:
- •Have active infectious systemic disease
- •Have active infectious ocular or extraocular disease
- •Have an obstructed nasolacrimal duct in the study eye(s) (dacryocystitis)
- •Have known hypersensitivity to dexamethasone or are a known steroid responder
- •Have a history of ocular inflammation or macular edema
- •Are currently being treated with immunomodulating agents in the study eye(s)
- •Are currently being treated with immunosuppressants and/or oral steroids
- •Are currently being treated with corticosteroid implant (i.e. Ozurdex)
- •Have a history of herpes simplex virus keratitis or present active bacterial, viral, or fungal keratitis in either eye
- •Have a history of complete punctal occlusion in one or both punctum
- •Currently use topical ophthalmic steroid medications
- •Are currently pregnant or nursing.
- •Are unwilling or unable to comply with the study protocol
- •Are determined by the Investigator to not be included for reasons not already specified (e.g., systemic, behavioral, or other ocular disease/abnormality) or if the health of the subject or the validity of the study outcomes may be compromised by the subject's enrollment
研究组 & 干预措施
Dextenza
Group 1 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate drops QID x 1 week, then Dextenza will be inserted at the one-week postoperative evaluation (Day 8).
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Prednisolone Acetate
Group 2 (20 eyes) will receive treatment with topical 1% Prednisolone Acetate for five weeks with dosing schedule: QID x 2 weeks, TID x 1 week, BID x 1 week, QD x 1 week.
干预措施: Prednisolone Acetate 1% (Drug)
结局指标
主要结局
Absence of anterior chamber cells
时间窗: at Day 14
SUN Scale (0 minimum/better to 4 maximum/ worse)
次要结局
- BCVA(Baseline (day 8) to day 37)
- Measuring Cell(Day 8, 14, 37)
- Eye Pain(Day 8, 14, 37)
- Ease of Visualization(Day 8, 14, 37)
- Dry Eye(Day 8, Day 14, and Day 37.)
- Central Macular Thickness(Baseline to Day 37)
- Insert Retention(Day 8 to 37 days)
- Number of subjects requiring rescue steroid(Day 8 to Day 37)
- Number of attempts to successfully insertion(Day 8)
- Number and Percentage of subjects with complete absence of cell(Day 8 to 37)
- Measuring Flare(Day 8, 14, 37)
- Ease of insertion(Day 8)