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临床试验/NCT02576483
NCT02576483招募中不适用

An Evaluation of Quality of Vision and Quality of Life With LASIK, SMILE and PRK Surgery in Physicians

Stanford University1 个研究点 分布在 1 个国家目标入组 700 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
700
试验地点
1
主要终点
Self-reported quality of vision and quality of life questionnaire

研究概览

简要总结

The principle investigator is evaluating self-reported quality of vision and quality of life in physicians undergoing LASIK, SMILE and PRK surgery.

详细描述

The participants will have a comprehensive eye examination once they express an interest in the study. This includes a slit lamp examination of the front of the eye and a dilated fundoscopic examination of the back of the eye. If there is any pathology noted that would exclude the participant from the study, then the investigator will inform the participant and make an appropriate referral. This is standard practice for laser in situ keratomileusis (LASIK) surgery, small incision lenticule extraction (SMILE) and photorefractive keratectomy (PRK) surgery.

If the participant is deemed appropriate for the study after a comprehensive examination including computerized videokeratography, then the participant can be enrolled. These exams are also standard practice for LASIK, SMILE and PRK surgery.

The Quality of Vision (QoV) Questionnaire will be administered following the pre-operative visit during which participants are enrolled and then at the three-month and twelve-month post- op visits before the participants are seen by the principle investigator. The questionnaire is the study intervention.

The participant will undergo bilateral simultaneous LASIK eye surgery, SMILE or PRK surgery. The participants will be seen pre-operatively, on the day of surgery, post op day one, one month, three months, and twelve-months as part of the study. Participants may also be seen more frequently if required from a medical standpoint. The participant will receive topical antibiotics in each eye for one week following the procedure. LASIK treated eyes will receive pred forte 1% ophthalmic drops for one week to four weeks after treatment. All of this is within the usual and customary standard of care for the treatment of patients undergoing LASIK, SMILE and PRK surgery.

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
21 Years 至 62 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Self-reported quality of vision and quality of life questionnaire

时间窗: Twleve months

次要结局

  • Changes in CDVA (Corrected distance visual acuity)(Preoperatively, one, three, six and twelve months)
  • Predictability (Percentage of eyes within 0.25, +/- 0.50 and +/- 1.00 diopters of the intended correction(Preoperatively, one, three, six and twelve months)
  • Self-reported quality of life and quality of vision (QoV questionnaire)(Preoperatively, one, three and six months)
  • Changes in low contrast acuity (5% and 25% contrast acuity)(Preoperatively, one, three, six and twelve months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Edward E. Manche

Principal Investigator

Stanford University

研究点 (1)

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