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临床试验/NCT03616600
NCT03616600已完成不适用

The Safety and Effectiveness of Clinical Performance of Breath-O Correct Orthokeratology Lenses

The Hong Kong Polytechnic University1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2018年3月1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
31
试验地点
1
主要终点
Corneal Endothelial Health in Terms of Endothelial Cell Density

研究概览

简要总结

In Hong Kong, approximately 80% of children are myopic by the end of childhood. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression. One of the most successful treatments for myopia is orthokeratology. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

详细描述

Short-sightedness (myopia) is the most common refractive error in the world. In Hong Kong, approximately 80% of children are myopic by the end of childhood. Current treatment strategies to control (i.e. slow) myopia progression in children are primarily designed to harness the natural "emmetropization" process, in which visual feedback from retinal image clarity regulates the rate of eye growth. There is intense interest currently in the potential role of peripheral defocus as a clinical treatment to slow myopia progression, not least since this approach permits clear central vision. One of the most successful treatments for myopia is orthokeratology, which is a therapy of using custom-made rigid gas permeable contact lens. The special design of this contact lens can reshape the corneal profile to minimize the central refractive error while producing beneficial peripheral defocus. Currently, Breath-O correct lenses are new designed ready-made orthokeratology lenses which are made of new material with more elasticity as compared traditional lens material. This study is to evaluate the safety of wearing this new orthokeratology lens and the effectiveness of clinical performance in young adult.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Refractive error: Spherical: normally -1.00D to -4.00D (maximum up to -5.00D); Cylindrical: normally half of Sph (against-the-rule Astigmatism.: lower than -0.75D) (maximum up to -1.50D)
  • Best corrected Visual acuity: monocular ETDRS 0.0 or better
  • Ocular health: No ocular abnormality, no contra-indications for overnight orthokeratology lens wear, no refractive surgery
  • General health: No systemic diseases
  • Requirement: No history of orthokeratology lens wearing. Agree to participate in this study and willing to wear the orthokeratology lenses overnight in accordance with the instructions given and to come back for follow up within the study period

排除标准

  • 未提供

结局指标

主要结局

Corneal Endothelial Health in Terms of Endothelial Cell Density

时间窗: Baseline, 1st Month, 3rd Month

measured by specular microscope

Corneal Endothelial Health in Terms of Percentage of Variation in Cell Size

时间窗: Baseline, 1st Month, 3rd Month

measured by specular microscope

Corneal Biomechanics in Terms of Corneal Hysteresis and Resistance Factor

时间窗: Baseline, 1st Month, 3rd Month

measured by ocular response analyser

Anterior Ocular Surface Evaluation in Terms of Non-invasive Keratography Break-up Time (NIKBUT)

时间窗: Baseline, 1st Month, 3rd Month

measured by OCULUS Keratograph® 5M

Anterior Ocular Health in Terms of Limbal and Bulbar Redness

时间窗: Baseline, 1st Month, 3rd Month

measured by OCULUS Keratograph® 5M and graded by JENVIS redness grading system It is a scale of 0 to 4, the higher the score, the more redness the ocular surface manifests

次要结局

  • Best Corrected Visual Acuity in Terms of High and Low Contrast(Baseline, 1st Month and the 3rd Month)
  • Reduction of the Refractive Power After Wearing the Breath-O-correct Lens(Baseline, 1st Week, 1st Month, 3rd Month)

研究者

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

Henry HL Chan, PhD

Assocaite Professor

The Hong Kong Polytechnic University

研究点 (1)

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