The Effect of Lifitegrast On Refractive Accuracy And Symptoms In Dry Eye Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error
研究概览
简要总结
To determine if Xiidra® lifitegrast plays a role in the refractive accuracy when administered to patients preoperatively who are scheduled for cataract surgery and have a tear break up time (TBUT) ≤ 10 seconds and central corneal staining as defined by the Oxford scale
详细描述
This will be a 4-week multicenter investigator-initiated study, in which a maximum of 200 subjects will be enrolled.
As many as two thirds of patients undergoing cataract surgery have dry eye. Often this latter condition is under treated i.e., any dry eye treatment such as artificial tears, that is being pursued in not adequately controlling the visually significant ocular surface disruption, and patient still have corneal staining or a reduced tear break-up time (TBUT).
The investigators hypothesize that lifitegrast administered at least 4-week prior to pre-operative biometry measurements will improve both the quality of measurements used to choose an intraocular lens implant for surgery and the symptoms of patients with this combination of conditions. This finding would suggest that pre-treatment with lifitegrast can improve both the accuracy of surgery and patient comfort.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with planned cataract surgery
- •Central or inferior corneal fluorescein staining defined by the Oxford Scale
- •Reduced tear break up time (TBUT) ≤ 10 seconds.
- •Able to comprehend and sign a statement of informed consent.
- •Willing and able to complete all required postoperative visits.
排除标准
- •Ocular surgery (e.g., intraocular, oculoplastic, corneal or refractive surgical procedure
- •Clinically significant ocular trauma.
- •Active ocular Herpes simplex or Herpes Zoster infection
- •Ocular inflammation (uveitis, iritis, scleritis, episcleritis, keratitis, conjunctivitis) at the discretion of the investigator.
- •Ocular infection (e.g., viral, bacterial, mycobacterial, protozoan or fungal infection or the cornea, conjunctiva, lacrimal gland, lacrimal sac or eyelids including hordeolum/stye).
- •Active, systemic or local disease condition that causes clinically significant ocular surface irritation such that it could interfere with the questions in the survey and examination findings.
- •Moderate to severe (Grade 2-4) allergic, vernal or giant papillary conjunctivitis.
- •Severe (Grade 3 or 4) inflammation of the eyelid (e.g., blepharochalasis, staphylococcal blepharitis or seborrheic blepharitis)
- •Eyelid abnormalities that significantly affect the lid function (e.g., entropion, ectropion, tumor, edema, blepharospasm, lagophthalmos, severe trichiasis, severe ptosis).
- •Ocular surface abnormality that may compromise the corneal integrity (e.g., prior chemical burn, recurrent corneal erosion, corneal epithelial defect, Grade 3 corneal fluorescein staining, map dot fingerprint dystrophy, or the effect of any other ophthalmic medication that might in the opinion of the investigator compromise the ocular surface integrity).
- •Participation in another ophthalmic clinical trial involving a therapeutic drug or device within 30 days prior to enrollment date.
- •Participation in this trial in the same patient's fellow eye
- •Patients who are pregnant or breastfeeding or who may become pregnant during participation in the study.
研究组 & 干预措施
Lifitegrast 5%
Patients will receive lifitegrast 0.5% eye drops twice daily 4 weeks prior to cataract surgery.
干预措施: Lifitegrast (Drug)
结局指标
主要结局
Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error
时间窗: 4 weeks
Increase accuracy of preoperative biometry at predicting postoperative equivalent refractive error after 4 weeks of lifitegrast ophthalmic solution (5%) BID.
次要结局
- Compare SPEED questionnaire scores before and after 4 weeks of lifitegrast treatment(4 weeks)
- Determine the percentage of patients with low SPEED scores(4 weeks)