Initial Correction Keratoconus: Scleral vs Corneal Gas Permeable Lenses SCOPE Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Final contact lens choice
研究概览
简要总结
Keratoconus is a non-inflammatory, progressive disease in which corneal irregularity increases. As the condition develops, more advanced forms of optical correction are needed to improve vision for patients. Until recently, small diameter corneal gas permeable lenses were considered the primary mode of correction for patients with keratoconus. Now, however, practitioners have multiple options for reducing the optical aberrations caused by keratoconus, including scleral lenses. As of yet, no single option for optical correction has been identified as the preferred mode of correction in terms of overall patient satisfaction with vision, comfort, and ease of use. The order in which various forms of optical correction would be most logically introduced has yet to be determined. This is a study comparing small diameter corneal gas permeable and large diameter scleral lenses in individuals with keratoconus.
This study will prospectively compare visual satisfaction and ease of use between corneal gas permeable and scleral lenses for patients with mild to moderate keratoconus.
详细描述
While both corneal gas permeable and scleral lenses have been show to improve visual acuity in individuals with keratoconus, it has yet to be determined if one option has superior comfort and overall patient satisfaction in patients new to gas permeable lens use. In this study, patients will be prospectively fit with both corneal gas permeable and scleral lenses according to standard clinical practice. Both corneal gas permeable and scleral lenses are considered standard of care for patients with keratoconus.
The investigators hypothesize that study participants will select scleral lens over corneal gas permeable lens as their preferred final lens type of choice.
The Primary outcome measure of this study is participant selected final lens choice for continued use for the management of keratoconus.
Methods:
Study Design This is a prospective, multi-center, randomized interventional clinical trial with a 2x2 crossover design of patients with keratoconus fit with corneal and scleral gas permeable contact lenses. The crossover design allows intra-subject differences between two randomized groups with participants serving as their own controls. Contact lens #1 will be the SynergEyes VS (Synergeyes, Inc., Carlsbad CA) which features bi-tangential toric peripheries with linear landing zones. The standard lens is 16.0mm and is available from 14.5 to 17.5mm diameters. Contact lens #2 will be the RoseK2 corneal gas permeable lens (Blanchard Contact Lens, Inc. Manchester, NH). The lens is available in with a base curve range from 4.30 to 8.60 mm, diameter of 7.90 to 10.40mm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of keratoconus
- •Available baseline corneal topography and pachymetry
- •Amsler-Krumeich keratoconus classification9 of stage 1
排除标准
- •No prior corneal transplantation or INTACTS
- •No prior use of hybrid, corneal or scleral gas permeable lenses
- •Presence of corneal scarring.
结局指标
主要结局
Final contact lens choice
时间窗: At study completion (6-24 weeks)
Each study participant will select whether to continue with Lens 1 or Lens 2. The percentage of those who choose a Scleral Lens will be compared to the percentage of participants who select corneal gas permeable lenses.
次要结局
- Subjective comfort with lens use(Baseline, Study Visit 1 (2-4 weeks), Study Visit 2 (4-10 weeks) and at study completion (6-24 weeks))
研究者
Ellen S Shorter
Associate Professor of Clinical Ophthalmology
University of Illinois at Chicago