The Evaluation of the Safety and Efficacy of Sustained Release Dexamethasone Intracanalicular Insert (DEXTENZA) in Pediatric Patients Following Retinal Surgery or Laser Treatment Under Anesthesia (TENDER)
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Pain as measured by the FLACC pain scale
研究概览
简要总结
The Tender Study is a prospective, open-label, single-center, randomized, investigator-initiated clinical study seeks to investigate the safety and efficacy of the DEXTENZA insert in pediatric patients following retinal surgery or laser treatment under anesthesia.
详细描述
The study aims to enroll 30 pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia. Patients in each treatment group (surgery or laser) will be randomized 2:1 at the time of surgery/laser to receive either:
- Treatment Arm: Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively, or
- Control Arm: Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QUID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.
Each treatment group (surgery or laser) will include 15 patients total, 10 receiving Dextenza and 5 receiving the control drug. Drops for dilation and antibiotic coverage will be used as clinically indicated in all groups throughout the study period. Follow up will occur at post-op day 1, 7, 28/30 and 45 ( +/- three days for all post-operative timepoints).
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
- 3 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pediatric patients undergoing routine retinal surgery or laser treatment under anesthesia for a variety of visual conditions. These conditions and procedures include but are not limited to:
- •Conditions:
- •Familial Exudative Vitreoretinopathy
- •Coats' Disease
- •Exudative Retinopathy
- •Lattice degeneration
- •Retinal holes
- •Sickler's syndrome
- •Retinal detachment, rhegmatogenous
- •Retinal detachment, exudative
- •Retinal detachment, tractional
- •Laser photocoagulation
- •Cryotherapy
- •Retinal detachment repair with scleral buckle and cryotherapy
- •Retinal detachment repair with vitrectomy
- •Written informed consent from parent/legal guardian
排除标准
- •Preprocedural
- •Active or history of chronic or recurrent inflammatory eye disease in either eye
- •Any patient of reproductive potential that has a positive pregnancy test during pre-procedural testing
- •Active or history of increased ocular pressure
- •Patients with active corneal, conjunctival, and canalicular infections
- •Patients with punctal stenosis or other punctal anatomical abnormalities that would not be conducive with device insertion
- •Nasolacrimal duct obstruction
- •Laser or incisional ocular surgery during the study period and 6 months prior in the study eye
- •current use of systemic or topical steroids or NSAIDS on a regular basis
- •History of autoimmune disease that may interfere with treatment/outcomes
- •Ocular pain at the time of screening
- •Known malignancy
- •Current use of cyclosporin or a TNF blocker
- •Ocular hypertension IOP >25, actively taking medications for ocular hypertension, any history of IOP spikes in either including steroid associated IOP elevation
- •Congenital ocular lid and tear duct system abnormalities (e.g. congenital ectropion/entropion, trichiasis)
- •Evidence of acute external ocular infection of the study eye
- •Active or history of HSV
- •Previous trauma causing deformity
- •Previous enrollment or current enrollment with another clinical trial within the last 30 days that may interfere with treatment
- •Known allergies to product under investigation
- •Inability to engage in VA testing
- •Investigator determines that the candidate is not eligible for participation based on clinical or historical factors that would interfere with treatment or impact patient safety not specified above
- •Current artificial tear use >4x daily
- •Current use of any topical ocular drops
- •Anyone who, in the opinion of the investigator, would not be a good candidate for the study.
- •Intraoperatively
- •Multiple procedures required
- •Complication occurs that surgeon determines makes the patient ineligible for study inclusion
- •Unsuccessful dilation of the punctum to 0.7mm when dilation attempted
- •during the exam under anesthesia, if it is decided that periocular Kenalog injection is indicated this patient fails screen and will no longer be eligible for the study
研究组 & 干预措施
Treatment Arm
Dextenza insert intraoperatively for perioperative ocular inflammation and pain. These patients will not be prescribed topical steroid drops post-operatively
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Control Arm
Prednisolone forte 1% steroid drop taper for 28 days post-operatively to treat perioperative ocular inflammation and pain; drops four times per day (QID) on days 0-7, three times per day (TID) on days 7-14, twice per day (BID) on days 14-21 and once per day (QD) on days 21-28.
干预措施: Pred Forte (Drug)
结局指标
主要结局
Pain as measured by the FLACC pain scale
时间窗: up to Day 45 post-op
The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.
Pain as Measured by the FLACC Pain Scale
时间窗: Baseline, post-op days 1, 7, 28, and 45
The Face, Legs, Activity, Cry and Consolability (FLACC) scale is an observational scale. comprised five behavioural indicators that are scored from zero to two. The pain score is the sum of the item scores and ranges from zero to 10. A lower score indicates minimal to no pain while high scores indicate moderate to severe discomfort.
次要结局
- Severity of Adverse Events(up to Day 45 post-op)
- Resolution of inflammation or less cell on follow up post op exams(up to Day 45 post-op)
- Degree of inflammation (AC cell count)(up to Day 45 post-op)
- Percentage of patients with rebound inflammation from baseline through post-op care(up to Day 45 post-op)
- Percentage of patients that were given supplementary prednisolone drops(up to Day 45 post-op)
- The number of drops needed in these patients(up to Day 45 post-op)
- Mean change in Best Corrected Visual Assessment (BCVA)(up to Day 45 post-op)
- Incidence of adverse events(up to Day 45 post-op)
- Resolution of pain(up to Day 45 post-op)
- Ratio of Intraocular pressure increase with insert(up to Day 45 post-op)
- Caregivers Treatment Adherence(up to Day 45 post-op)
- Number of Participants With Adverse Events(Up to post-op day 45)
- Severity of Adverse Events(Up to post-op day 45)
- Ocular Inflammation (AC Cell Count)(Baseline, post-op days 1, 7, 28, and 45)
- Percentage of Participants With AC (Anterior Chamber) Cell(Post-op days 1, 7, 28, and 45)
- Number of Participants With Resolution of Pain(up to 45 days post-op)
- Change in Absolute Intraocular Pressure (IOP)(Post-op days 1, 7, 28, and 45)
- Number of Participants With Rebound Inflammation(up to 45 days post-op)
- Number of Treatment Participants Who Were Given Supplementary Prednisolone Drops(up to 45 days post-op)
- Number of Supplemental Drops Needed in Treatment Participants(up to 45 days post-op)
- Median Change in Best Corrected Visual Assessment (BCVA) From Baseline(baseline, post-op days 1, 7, 28, and 45)
- Caregivers Treatment Adherence(Day 45 post-op)
研究者
Lejla Vajzovic, MD, FASRS
Principal Investigator
Duke University