Effect of Cequa Treatment on Accuracy of Pre-operative Biometry and Higher Order Aberrations in Dry Eye Patients Undergoing Cataract Surgery
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 74
- 试验地点
- 3
- 主要终点
- Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
研究概览
简要总结
The purpose of this study is to examine the effect of Cequa treatment on the accuracy of pre-operative biometry and on corneal higher-order aberrations (HOAs) in cataract patients who have signs of dry eye disease.
详细描述
Hypothesis: In patients with dry eye, defined as corneal staining and a reduced tear breakup time, the accuracy of pre-operative biometry and corneal surface HOAs will improve significantly after four weeks of Cequa treatment.
Primary Outcome Measure: Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
Secondary Outcome Measures:
The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.
The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with planned cataract surgery,
- •The presence of 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) performed within the last 3 months or at any time that in the investigator's clinical judgment if it would interfere with the outcome measures of this study.
- •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 study 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 this trial in the same patient's fellow eye
- •Patients who are under age 18, pregnant or breastfeeding, or who may become pregnant during participation in the study.
研究组 & 干预措施
Cequa Treatment In Cataract Patients with Dry Eye Disease
Duration of Study Treatment - 4 weeks All patients will receive cyclosporine ophthalmic solution (0.09%) BID in both eyes for 28 days, 1 drop per dose. Dosing will be BID, both eyes, assuming both eyes will eventually undergo cataract surgery. Otherwise, single eye treatment in the operative eye will be permitted.
干预措施: Cequa (Drug)
结局指标
主要结局
Spherical equivalent prediction error of pre-Cequa vs post-Cequa ocular biometry performed for cataract surgery.
时间窗: Four weeks
次要结局
- The difference in SPEED questionnaire scores before and 4 weeks after Cequa treatment.(Four Weeks)
- The impact of Cequa treatment on corneal higher order aberrations measured in the central 6 mm of the cornea.(Four Weeks)
- The difference in corneal staining before and after treatment with Cequa.(Four Weeks)
- The difference in tear breakup time (TBUT) before and after treatment with Cequa.(Four Weeks)