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临床试验/NCT04724525
NCT04724525已完成不适用

The Effect of Changes in Power and Cylinder Axis on Vision Quality, Satisfaction and Vision Acceptability of People With Mild-Medium Astigmatism With Toric Soft Contact Lenses (LKL)

Indonesia University2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2020年11月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
Change in Visual Acuity

研究概览

简要总结

Astigmatism is a common refractive error resulting from a toric-surfaced cornea which using a toric soft contact lens could be one of the therapy options. Due to the numerous possible combinations between sphere powers, cylinder powers, and cylinder axes, manufacturers of disposable soft toric contact lenses limit their toric lens range, while still aiming to cater to the majority of astigmatic patients. Due to that reason, the possibility of astigmatism patients getting a different combination of power and axis with toric soft contact lenses sold on the market will be high due to SKU limitations. This research aims to ascertain the impact of altering cylinder power and axis on visual quality and convenience in astigmatism participants using toric soft contact lens. The study was conducted at Kirana Ciptomangunkusumo Hospital, Jakarta, starting in April 2020. The study is a prospective, randomized, participant-masked, crossover clinical trial where the participants were tested for the following conditions on different days using full spherocylinder correction and under-correction by 0.25, 0.50, and 0.75 DC while maintaining spherical equivalence. Axis was also misaligned between -30° and +30°, in 10° steps. For each visit, the patient was examined visual acuity, contrast visual acuity using the Pelli-Robson, and assessed patient comfort using the VAS method.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Screening
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 35 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 20 - 35 years
  • Patients who do not have a spherical size (plano) to mild-moderate myopia (-1.00 D to -6.00 D) with age over 18 years
  • Minimum astigmatism component ≥0.75 D and maximum ≤ 3 D in one eye
  • The best visual acuity after corrected by LKL Torik is better or equal to 6/15

排除标准

  • History of previous intraocular surgery.
  • History of contact lens use in the last 6 months.
  • history of dry eyes, uveitis, glaucoma and corneal and conjunctival disorders
  • posterior segment abnormalities that reduce the quality of vision
  • Patients with contraindications to wearing contact lenses
  • There are no toric LKLs with exactly the strength and axes required by the patient

结局指标

主要结局

Change in Visual Acuity

时间窗: when using a contact lens (0 day,7 days, 14 days)

Visual acuity was measured using a Snellen chart at a distance of 6 meters by the researcher (DA) at Refractive Poly

次要结局

  • Visual Satisfaction(when using a contact lens (0 day,7 days, 14 days))
  • Change in Contrast sensitivity(when using a contact lens (0 day,7 days, 14 days))
  • Visual Clarity(when using a contact lens (0 day,7 days, 14 days))

研究者

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

Dwie Aprina

Principal investigator

Indonesia University

研究点 (2)

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