Evaluation Of Vision Recovery And Comfort Index In Patients With Borderline/Mild Dry Eyes Undergoing Femtosecond Laser-Assisted Cataract Surgery With Premium Intraocular Lens - The ENHANCE Study
试验速览
- 阶段
- 4 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
研究概览
简要总结
This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%.
详细描述
This is a prospective, open-label, single-center, randomized, head-to-head, investigator-sponsored clinical study. It aims to investigate the vision recovery and patient comfort in borderline/mild dry eye disease patients undergoing FLACS with Premium PCIOL (i.e., Panoptix, Toric IOL (spherical/multifocal), ReStor, Symfony), receiving a 0.4mg dexamethasone intracanalicular insert when compared to patients receiving standard of care prednisolone acetate 1%. After screening a given patient for inclusion and exclusion criteria, and gaining informed consent, a total of 30 patients will be randomized into two groups:
Group 1: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive a 0.4mg dexamethasone intracanalicular insert at the days of each surgery.
Group 2: 15 patients will undergo bilateral FLACS + Premium PCIOL in separate days and will receive prednisolone acetate 1% QID/ 1 week, TID/ 1 week, BID/1 week, QD/ 1 week regimen starting at the days of each surgery.
All patient eyes will receive Prolensa 0.07% ophthalmic solution QD for 4 weeks starting 3 days prior to surgery and Besivance 0.6% eye drops TID/starting 3 days prior to surgery.
Per enrolled eye, the study period will last for approximately 30 days after surgery, consisting of three postop follow-up visits (six total postop visits per patient). At Day 1, Day 7 and Day 30, primary and secondary endpoints will be assessed alongside standard-of-care procedures. SPEED questionnaire will be assessed by a masked survey administrator. Adjusting for enrollment period, the study will last a total of approximately 12 months, including submission for publication/ presentation.
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
- 否
入选标准
- •Demonstrate objective signs of Boderline/ Mild Ocular Surface Disease (OSD) [defined as mild symptoms, mild conjunctival staining (<2+ Superficial Punctate Keratitis), Tear Break-up Time <12s] or demonstrate symptoms of OSD determined by SPEED questionnaire (SPEED Score <10).
- •Nucleus sclerosis up to 2+ planning to undergo FLACS + Premium PCIOL in both eyes.
- •Ability to provide informed consent for procedures
- •Ability to attend scheduled follow up visits
- •No other corneal pathology to create unknown variability
排除标准
- •Age less than 18
- •Pregnancy/currently breast-feeding
- •Inability to provide informed consent
- •Documented adverse reaction to steroid (e.g. "steroid responder", allergy, etc)
- •Punctal stenosis
- •Previous corneal transplant surgery or refractive surgery
- •Concurrent use of topical steroid eye drops
- •Systemic, topical or intravitreal steroid use within 1 month of baseline
- •Active history of chronic or recurrent inflammatory eye disease in either eye
- •History of ocular herpetic infection (inclusive of Herpes Simplex 1/2, Varicella Zoster, Epstein Barr, Cytomegalovirus)
- •History of neurotrophic keratitis, uncontrolled diabetes, or other disease entities that may preclude proper healing
- •Diagnosis of Glaucoma or use of topical glaucoma drops
- •Participation in other studies in the last 6 months
研究组 & 干预措施
Dextenza Arm
干预措施: Dextenza 0.4Mg Ophthalmic Insert (Drug)
Prednisolone Acetate 1%
干预措施: Prednisolone Acetate (Drug)
结局指标
主要结局
Mean change in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)
时间窗: Baseline, Post-Operative Day 7 and Day 30
As measured by Best Corrected Visual Acuity (BCVA) from baseline and at 1 week and 30 days after surgery
Mean change in uncorrected Visual Acuity (VA)
时间窗: Baseline, Post-Operative Day 7 and Day 30
As measured by uncorrected VA from baseline and at 1 week and 30 days after surgery
Mean change from baseline in Standardized Patient Evaluation of Eye Dryness (SPEED) score
时间窗: Baseline, Post-Operative Day 7 and Day 30
As measured by SPEED score from baseline and at 1 week and 30 days after surgery
次要结局
- Mean change from baseline in (Central Subfield Thickness) CST(Post-Operative Day 7 and 30)
- Patient satisfaction with vision at 1 week and 30 days after surgery(Post-Operative Day 7 and Day 30)
- Mean change in corneal staining(Baseline and at POD 7 and POD 30)
- Mean number of artificial tear drops dosed per day(30 Day tear log.)
- Mean change in tear break-up time (TBUT)(Baseline and at POD 7 and POD 30)
- Mean change in tear osmolarity(Baseline and at POD 7 and POD 30)
研究者
Dr. John Passarelli
Principle Investigator
Sight Medical Doctors PLLC