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临床试验/NCT04334369
NCT04334369撤回不适用

Does Specialty Soft Contact Lens Wear Decrease the Onset and Progression of Myopia in Optometry School Interns?

Jeff Rabin2 个研究点 分布在 1 个国家开始时间: 2018年12月12日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Contact Lenses and Myopia Progression

研究概览

简要总结

The purpose of the study is to determine the effect of Natural View Multifocal lenses, a soft multifocal lens, on retardation of myopia in an optometric student population. Close up work (i.e. reading, computer work, etc.) is thought to play a factor in the progression of myopia in young adults. The progression should be slowed if not stopped through the use of peripheral defocus lenses (Natural View Multifocal) to change the optics of the eye in order to focus the image on the peripheral retina as opposed to behind it.

详细描述

BACKGROUND AND SIGNIFICANCE Myopia is a common refractive error that has increased among young adults and has become more prevalent in the growing population across the globe (Fan, et al 2004). This has been more common in Eastern Asian countries with prevalence of myopia as high as 96.5% among 19 year old soldiers in South Korea. (Shimuzu, et al 2003) In the United States between the 1990's to the 2000's there was a sudden increase of >15% myopia progression (Vitale et al 2009). There has been a correlation between education and myopia progression in urban areas calling into question the amount of close up work and being indoors as opposed to being outside working as in the rural populations (Resnikoff, et al 2004). Children between the ages of 7 to 11 years that were forced to spend 80 minutes per day outside showed a significantly better outcome in regards to onset as well as progression of myopia. Those that were spending 80 minutes per day outside had an average onset of 8.4% and progression of 0.25 diopters whereas the children that were not forced to spend time outside had onset and progression at a rate of 17.7% and 0.38 diopters respectively. (Wu, et al 2013) Myopia progression has become a cause for concern due to the complications that arise from the elongation of the eye. Some of the complications include retinal detachment, choroidal thinning, glaucoma and myopic macular degeneration. In a study of the causes of visual impairment in an adult Chinese population, it was found that myopic macular degeneration was the leading cause of bilateral visual impairment in adults between the ages of 45 and 59 years old and the second highest major cause of bilateral blindness. (Tang Y, et al 2015) Pathological myopia is one of the leading causes of blindness that can be prevented (Kang et. al. 2017).

Recent studies have promising conclusions that soft multifocal contact lenses are a viable option for slowing myopia progression. Many studies have been conducted on the topic of myopic control with soft multifocal contact lenses in young patients. Very little data exists on myopia control methods used in young adults. It is often thought that myopic progression will progress even through to young adults which could potentially necessitate a need for control. If the use of Dual-Focus soft contact lenses in young adults controls myopia, this could become a viable, cost effective method to increase productivity around the world. This is an important factor to consider as the direct and indirect cost of loss of productivity due to uncorrected refractive error is 202 billion dollars. (WHO bulletin 2004). Reducing the negative side effects of myopia and possible reduced vision loss in this specific population can open doors to future research in other populations.

A common treatment for myopia progression is Orthokeratology, in which patients wear a rigid gas permeable contact lens overnight in the hope of reshaping their corneas. A major concern however, with this treatment is the increased risk of infection that comes with wearing a lens overnight. It is also not approved for use on patients with a refractive error of >6.00D of myopia, and is not effective in older adult patients (Cooper et al 2017). Another pitfall of Orthokeratology is that once treatment is stopped, the refractive error of the patient returns to normal. This treatment regimen is easily restricted due to the high cost to the patient. This in turn calls for a type of treatment that can be used during the day, is cost effective, and can be easily disposed of to decrease the risk of infection. If the daily multifocal soft contact lenses are used correctly, any risk of infection or major drawback is greatly reduced. Another method of treatment involves the use of Atropine, which has proven to be successful in controlling the advancement of myopia. This however has side effects including blurry vision, increased sensitivity to light, possible flushing, tachycardia, bradycardia and other undesirable side effects. As the dose of Atropine rises, the reported side effects also increase. (Huy et. al. 2017).

LOCATION, FACULTY AND EQUIPMENT TO BE USED

  • University of Incarnate Word Rosenberg School of Optometry Eye and Vision Care Clinic
  • IOL Master 500 by Zeiss
  • Topography
  • Pentacam

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

性别
All
接受健康志愿者

入选标准

  • Be first or second year Optometric students at RSO
  • Be non-presbyopic
  • Have at least -0.50 Diopters or more of myopia in one or both eyes
  • Have no systemic health issues
  • Have no previous history of Orthokeratology
  • Have no gas permeable contact use in the last 6 months
  • Not be enrolled in any other eye study
  • Be able to have a cycloplegic refraction
  • New and existing contact lens wearers

排除标准

  • Progressive retinal or corneal disorder as well as any of the above

结局指标

主要结局

Contact Lenses and Myopia Progression

时间窗: 3years

Progression of Myopia in Diopters

次要结局

未报告次要终点

研究者

发起方
Jeff Rabin
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jeff Rabin

PROFESSOR AND ASSISTANT DEAN

University of the Incarnate Word

研究点 (2)

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