In Clinic Optometrist Insertion of Dextenza Prior to Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean Anterior Chamber Cell/Flare Score
研究概览
简要总结
To evaluate the clinical outcomes with optometrist pre-surgical insertion of DEXTENZA in the clinical office setting in patients undergoing same-day cataract surgery compared to standard of care steroid therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
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
- •Patients 18 years of age or older, undergoing routine, uncomplicated, sequential bilateral cataract surgery.
- •Willing and able to comply with clinic visits and study related procedures
- •Willing and able to sign the informed consent form
排除标准
- •Patients under the age of
- •Patients who are pregnant (must be ruled out in women of childbearing age with pregnancy test).
- •Active infectious ocular or systemic disease.
- •Patients with active infectious ocular or extraocular disease.
- •Patients actively treated with local or systemic immunosuppression including systemic corticosteroids.
- •Patients with known hypersensitivity to Dexamethasone.
- •Patients with severe disease that warrants critical attention, deemed unsafe for the study by the investigator.
- •Patients with proliferative diabetic retinopathy or uncontrolled diabetes as deemed by an A1C > 10.
- •Patients with a history of ocular inflammation or macular edema.
- •Patients with a pre-existing epiretinal membrane (ERM)
- •Patients with allergy or inability to receive intracameral antibiotic.
- •Patients on systemic non-steroidal anti-inflammatory drugs (NSAID) greater than 1,200 mg/day The PREPARE Study (V1) February, 2021 Page 27 CONFIDENTIAL
- •Patients with a corticosteroid implant (i.e. Ozurdex).
研究组 & 干预措施
Group A Dextenza
Randomized to dexamethasone ophthalmic insert 0.4mg placed prior to cataract surgery, on the day of surgery.
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Group B Topical Prednisolone
Randomized to topical prednisolone acetate 1% four times per day for one week, three times per day for one week, two times per day for one week, and one time per day for one week starting after 4 hours after surgery.
干预措施: Topical prednisolone acetate (Drug)
结局指标
主要结局
Mean Anterior Chamber Cell/Flare Score
时间窗: Post-op Day 7
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.
Number of Eyes With No Cell or Flare Measured
时间窗: post-op Week 4.
Mean anterior chamber cell/flare score measured by Slit Lamp Biomicroscopy evaluation using grading scale of 0 to 4 +. The scale used is called the (Standardization of Uveitis Nomenclature) SUN Working Group Grading Scheme. AC cell grading schema. The SUN Working Group defined their two AC grading schemas around these two findings. Importantly, for all grading schemas discussed in this article, an improvement in inflammation is a two-step decrease in grade. A worsening of inflammation occurs with a two-step increase in grade. Grade 0 = 0 cells per high power field or HPF; Grade 0.5+ = 1-5 cells HPF; 1+ = 6-15 HPF; 2+ = 16-25 HPF; 3+ = 26-50 HPF; 4+ \>50. The higher the HPF, the more inflammation that can negatively impact a patient's outcome.
Mean Pain Score
时间窗: Post-op Day 1
Mean pain score measured by Visual Analog Score numerical grading scale 0(minimum)-10(maximum) 0= absence of pain 10 = highest possible pain A higher number indicates a higher pain value which may impact a subject's outcomes.
Patient Tolerability (Defined as Patient Preference)
时间窗: Post-op Week 4
As measured by adapted COMTOL (Comparison of Ophthalmic Medications for Tolerability) Questionnaire. The COMTOL questionnaire is designed to assess the tolerability of topical ophthalmic medications. It consists of several elements that help evaluate the frequency, severity, and impact of common side effects: Section 1: Ocular Side Effects; Section 2: Local Side Effects; Section 3: Visual Function; Section 4: Impact on Quality of Life. Likert scale is used to measure each question. 1=Never, 2=Rarely, 3=Sometimes, 4 = Often, 5= Always. A higher score suggests that the medication is less well-tolerated and may be negatively impacting the patient's daily activities and overall well-being.
次要结局
- Physician Ease of Use(Day 0)
- Number of Participants With Increased Intraocular Pressure (IOP) >10mmHg Above Baseline(postop Week 4)
- Number of Participants With Post-operative Cystoid Macular Edema (CME)(post-op Week 4)
- Eye Drop Burden Reported by Participants(post-op Week 4. Patients were not asked to differentiate between eyes when answering the eye drop burden questionnaire)