A Comparison of Ocular Health and Visual Quality With Corneal and Scleral Rigid Gas Permeable Lenses in Keratoconus Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Visual Acuity
研究概览
简要总结
This study aims to compare the ocular health and visual quality of corneal rigid gas permeable lenses (CRGPL) and scleral rigid gas permeable lenses (SRGPL) for patients with keratoconus in a crossover clinical trial. The study will analyze subjective and objective outcomes, including best corrected visual acuity, contrast sensitivity, higher-order aberrations and subjective perception of visual function and comfort. It will also investigate the impact of both lens types on the health of the ocular surface, including evaluation of corneal, conjunctival, and scleral tissues, and tear film. Only one randomized controlled trial has compared the effect of CRGPL and SRGPL wear for patients with an ectatic corneal disorder. With the increasing popularity of SRGPL, examining the differences in efficacy, safety, and patient-reported outcomes between the two types of lenses is increasingly relevant.
详细描述
A comparison of ocular health and visual quality with corneal and scleral rigid gas permeable lenses in keratoconus patients
- Introduction
1.1 Purpose: Keratoconus is an ocular disease, causing progressive thinning and steepening of the cornea, which results in irregular astigmatism and reduced visual quality. Irregular astigmatism induced by an irregular anterior cornea can effectively be corrected with rigid gas permeable (RGP) lenses. The purpose of this study is to compare subjective and objective outcomes from corneal rigid gas permeable lens (CRGPL) and scleral rigid gas permeable lens (SRGPL) wear in patients with keratoconus.
The following three aims will be pursued during a randomized clinical trial (RCT)
- To compare the subjective perception of visual function (SPVF), subjective perception of comfort (SPC) and objective measures for visual quality, including best corrected visual acuity (BCVA) and contrast sensitivity (CS), between CRGPL and SRGPL wear, for patients diagnosed with keratoconus.
- To analyze the effect of CRGPL and SRGPL on higher order aberrations (HOA) for patients with keratoconus.
- To investigate the impact of CRGPL and SRGPL wear on the ocular surface, including analysis of the corneal, conjunctival, and scleral tissue, as well as tear film analysis, for patients with keratoconus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Keratoconus, best spectacle corrected visual acuity >0.00 log of minimum angle of resolution (logMAR) and age between 18 to 40
排除标准
- •K-max >60D, RGP lens wear at baseline and ocular surface disease, verified through examination of the ocular surface and patient history
研究组 & 干预措施
Scleral Rigid Gas Permeable Contact Lens
Large diameter RGP lens (TD>HVID).
干预措施: Onefit MED (Device)
Corneal Rigid Gas Permeable Contact Lens
Small diameter RGP lens (TD < HVID).
干预措施: Rose K2 (Device)
结局指标
主要结局
Visual Acuity
时间窗: 6 weeks with each intervention. 13 weeks total, incl. 1 week washout.
Comparison of Best Corrected Visual Acuity, with the two interventions, at the end of 6 weeks of lens wear. Measured with ETDRS charts, converted to logMAR units.
次要结局
- Contrast Sensitivity(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Higher Order Aberrations (HOA)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Tear break-up time (TBUT)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Anterior ocular health markers(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Corneal Epithelial Thickness(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Corneal Tomography(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Subjective Perception of Comfort (SPC)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Dry Eye Symptoms(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Contrast Sensitivity(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Higher Order Aberrations (HOA)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Dry Eye Symptoms(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Tear break-up time (TBUT)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Subjective Perception of Comfort (SPC)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Anterior ocular health markers(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Corneal Epithelial Thickness(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Corneal Tomography(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)
- Subjective Percepton of Visual Function (SPVF)(6 weeks with each intervention. 13 weeks total, incl. 1 week washout.)