The Effects of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Change From Baseline in Macular Thickness Measurement - Number in Microns
研究概览
简要总结
This study evaluates the effect of Intraocular Phenylephrine/Ketorolac Infusion on Retinal Thickness and Macular Edema in Cataract Surgery. Participants will receive infusions of Phenylephrine/Ketorolac during surgery instead of receiving topical NSAID drops pre and post operatively.
详细描述
Topical NSAIDs have been known to reduce post-operative macular edema, inflammation and pain in patients undergoing cataract surgery. Routine cataract surgery without the protection of topical NSAIDs results in an increase of the number of patients with macular edema and macular thickening.
Omidria (phenylephrine and ketorolac injection 1%/0.3%) infusion is used in patients during cataract surgery to decrease post-operative pain and inflammation. It is also indicated to maintain pupil dilation during cataract surgery.
This study will evaluate whether treating patients with Omidria during cataract surgery will control post-operative pain and inflammation as well as reduce or eliminate macular edema without the use of adjunctive topical NSAIDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 55 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 55-90 years with visual significant cataracts in one or both eyes.
- •Healthy individuals able to tolerate outpatient cataract surgery under local anesthesia via either phacoemulsification and/or femtosecond assisted cataract surgery. Well-controlled diabetes, hypertension will be included.
- •Females of childbearing potential must agree to use a reliable method of birth control while participating in this study. Reliable methods of birth control are: abstinence, oral contraceptives, intrauterine device (IUD), DepoProvera, tubal ligation or vasectomy of the partner (with confirmed negative sperm counts) in monogamous relationship (same partner). An acceptable, although less reliable, method involves the careful use of condoms and spermicidal foam or gel and/or cervical cap or sponge. A pregnancy test is required at least 10 days from the last normal menstrual period, if the patient is a sexually active female of childbearing potential.
排除标准
- •Allergy to Phenylephrine or NSAIDs.
- •Inability to sit steady and upright for the Optical Coherence Tomography (OCT).
- •Complications during surgery, including posterior capsular rupture, vitreous loss, zonular dialysis, or iris trauma.
- •Macular thickness above 300 microns at baseline
- •Currently taking a prostaglandin analogue
- •Presence of an epiretinal membrane on the preoperative OCT.
- •Retained lens fragment post-operatively.
- •Inability to return for follow appointments
- •Female patients who are pregnant, lactating or planning to become pregnant during the course of treatment.
研究组 & 干预措施
Omidria
Phenylephrine/Ketorolac (1%/0.3%) will be administered to all participants enrolled into the study.
干预措施: Omidria (Drug)
结局指标
主要结局
Change From Baseline in Macular Thickness Measurement - Number in Microns
时间窗: Baseline and week 6
The thickness of the macula will be measured pre and post operatively using ocular imaging to determine if Omidria is sufficient in controlling thickening post-operatively - measured in number of Microns
Best Corrected Visual Acuity (BCVA) (Pre-op)
时间窗: Baseline
Best vision will be tested with lens correction using Snellen Charts.
Best Corrected Visual Acuity (BCVA) (Week 2)
时间窗: 2 weeks
Best vision will be tested with lens correction using Snellen Charts to determine if improvements have been made post-operatively.
Best Corrected Visual Acuity (BCVA) (Week 6)
时间窗: 6 weeks
Best distance vision will be measured clinically to determine if improvements have been made post-operatively.
Number of Participants That Develop Presence of Cystoid Macular Edema (CME)
时间窗: 2 weeks
The number of participants that develop CME will be recorded to evaluate if Omidria is sufficient in controlling CME. The presence of CME will be determined clinically.
Number of Participants Needing NSAID Post-operatively
时间窗: Post-op weeks 1 through 6
Need for topical NSAID (rescue med) will be assessed at all post-op visits. If at any time the patient shows signs of cystoid macular edema, inflammation or pain, NSAIDs will be administered. The number of patients needing NSAID post-operatively will help determine if NSAIDS are needed.
Change in Anterior Chamber Cells From Baseline Measurement
时间窗: Week 6
Anterior chamber cells will be assessed through a dilated eye exam to determine if NSAIDS are needed post-operatively in addition to Omidria during surgery. Range and meaning (if score/scale): 0-2 0 = no cell 1. = 10-20 cells 2. = greater than 20 cells
次要结局
未报告次要终点