CHOICE OF SUBJECTIVE OCULAR REFRACTION TECHNIQUE AND CORNEAL TOPOGRAPHY OF KERATOCONUS
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 1
- 主要终点
- Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
研究概览
简要总结
Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used.
The subjective refraction techniques of keratoconus-carrying patients have never been studied.
The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus.
The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.
详细描述
Keratoconus is a rare evolving corneal ectasia that alters visual acuity. To improve spectacle-corrected visual acuity, various subjective refraction techniques can be used. The Jackson Cylinder Cross Method, the Astigmatic Dial Technique and the Stenopeic Slit are three validated subjective refraction techniques for measuring astigmatism. The subjective refraction techniques of keratoconus-carrying patients have never been studied.
The main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus.
The investigators collect several characteristics of corneal topography of the keratoconus : the average value of the keratometry of the 3 central mm called Km ; the value of the point corresponding to the maximum keratometry (called Kmax), the distance between the center and the point of Kmax, (called d_Kmax) ; the corneal surface variance index called ISV ; the Belin/Ambrósio Enhanced Ectasia Display (called BAD-D).
The main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •adult persons
- •patients with keratoconus
- •patients with alteration of visual acuity
- •ability to give informed consent to participate in the study
- •affiliation to a social security scheme
排除标准
- •Keratoconus grafted with cornea or with intracorneal rings.
- •Central corneal opacities.
- •Presence of other eye diseases affecting visual acuity.
- •Patients under guardianship, curatorship or justice protection.
- •Pregnant or breastfeeding women.
- •Refusal to participate in the study.
研究组 & 干预措施
Cohort 1
70 patients are involved and will perform the three conditions.
干预措施: Cylinder (Behavioral)
Cohort 1
70 patients are involved and will perform the three conditions.
干预措施: Dial (Behavioral)
Cohort 1
70 patients are involved and will perform the three conditions.
干预措施: Slit (Behavioral)
结局指标
主要结局
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
时间窗: day 1
Measure of the Belin/Ambrósio Enhanced Ectasia Display (BAD-D)
Measure d_Kmax
时间窗: day 1
Measure of the distance between the center and the point of Kmax, (called d\_Kmax)
Measure of keratometry (Km)
时间窗: day 1
average value of the keratometry of the 3 central mm called Km
Measure of index of surface varaiance
时间窗: day 1
measure of the corneal surface variance index called ISV
Measure of the maximum keratometry
时间窗: day 1
value of the point corresponding to the maximum keratometry (called Kmax),
次要结局
- ametropia value(day 1)
- Subsequent modification of the eyeglasses by the optician(day 30)
- astigmatism axis(day 1)
- possible method(day 1)