NCT01441895Unknown不适用
A Post Market Pilot Study To Evaluate Corneal Sensation And The Incidence Of Dry Eye In Subjects Undergoing Refractive Cataract Extraction With The Femtosecond Laser For Arcuate Relaxing Incisions
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Corneal Sensitivity Testing
研究概览
简要总结
The study objective is to assess changes in corneal sensation and dry eye signs and symptoms following cataract extraction/femtosecond arcuate relaxing incisions.
Our clinical hypothesis is to determine if a combination of cataract surgery and femtosecond arcuate relaxing incisions lead to a reduction in corneal sensation and the onset or worsening of dry eye signs and symptoms.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Male or female subjects 18 years or older, in good general health
- •Prior to signing the Institutional Review Board approved Informed Consent Form / Health Insurance Portability and Accountability Act subject read and gained an understanding of the contents
- •Subject scheduled for cataract extraction with intraocular lens and requiring two (2) femtosecond arcuate relaxing incisions for correction of corneal astigmatism
- •Subject has greater than or equal to 1.0 D and less than or equal to 2.5 Diopters of corneal astigmatism as measured by keratometry or corneal topography
- •Two (2) arcuate incisions should be 45° in length and 180° apart.
- •All arcuate relaxing incisions will be placed exactly 4.5 mm from the visual axis for a 9 mm optical zone.
- •Corneal sensation at Screening by Cochet-Bonnet Aesthesiometry with floor stand >50 mm in all five regions
- •Be willing / able to return for all required study visits and comply with instructions given by study staff
- •Potential for best corrected visual acuity post cataract surgery of 20/20
排除标准
- •Uncontrolled inflammation not related to dry eye
- •Corneal abnormality that can affect corneal sensation or tear film stability (except superficial punctate keratitis (SPK)).
- •History of ophthalmic herpes simplex or zoster keratitis
- •OSDI score > 32
- •Active ocular allergy
- •History of refractive surgery or any surgery involving conjunctival, arcuate or corneal incision
- •Contact lens wear during the study. Soft contact lens wearers should discontinue use at least two weeks prior to Screening visit. Rigid gas permeable (RGP) or hard contact lens wearers should discontinue use at least one month prior to Screening visit.
- •Dry eye secondary to Vitamin A deficiency, scarring, pemphigoid, alkali burns, Stevens-Johnson syndrome, trachoma, or irradiation.
- •Currently using, or have used within 14 days of study enrollment, any ocular medications other than artificial tears
- •Use of topical cyclosporine (Restasis) within three months of Screening visit.
- •Have an uncontrolled systemic disease (e.g., hypertension, diabetes) or the presence of any significant illness (e.g., serious gastrointestinal, renal, hepatic, endocrine, pulmonary, cardiac, neurological disease, cancer, AIDS, or cerebral dysfunction) that could, in the judgment of the investigator, jeopardize subject safety or interfere with the interpretation of the results of the study
- •Temporary or permanent occlusion of the lacrimal puncta
- •Require chronic use of systemic medications which may induce or affect a dry eye condition (e.g., anticholinergics, cyclosporine, antihistamines, antimuscarinics, beta-blocking agents, tricyclic antidepressants, phenothiazines, estrogen-progesterone, and other estrogen derivatives), unless that medication has been used in the same dose for at least 3 months and is expected to remain constant for the course of the study
- •Current or anticipated use of nutritional supplements (e.g. flax seed oil, fish oil, omega-3 supplements) which may affect a dry eye condition.
- •Are currently enrolled in any other clinical study or have participated in such a study within 30 days of entry into this study
- •Is pregnant, breast-feeding, planning a pregnancy, or not using a reliable method of contraception. Subjects who become pregnant during the study will be discontinued from further study participation.
- •Have a condition or are in a situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with their participation in the study.
结局指标
主要结局
Change in Corneal Sensitivity Testing
时间窗: Change from Screening to Month 3
Subject lies supine with the test line of the Cochet-Bonnet Aesthesiometer suspended over the cornea to measure the sensation of touch on the eye. Testing is done in a standard manner by an experienced operator.
次要结局
- Ocular Surface Disease Index (OSDI)(Change from Screening to Month 3)
- Artificial Tear Use(Change from Screening to Month 3)
- Corneal and Conjunctival Staining(Change from Screening to Month 3)
- Subject Dry Eye Questionnaire(Change from Screening to Month 3)
- Tear Break Up Time (TBUT) with Biomicroscopy(Change from Screening to Month 3)
- Best Corrected Visual Acuity (BCVA)(Change from Screening to Month 3)
- Intraocular Pressure (IOP)(Change from Screening to Month 3)
研究者
研究点 (1)
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