Comparison of Corneal Collagen Cross-Linking Performed With "Epi-ON" Versus "Epi-OFF" Techniques in Eyes With Keratoconus and Other Corneal Ectatic Disorders
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 550
- 试验地点
- 1
- 主要终点
- Mean change in corneal curvature
研究概览
简要总结
This is a prospective, randomized, single investigative site study to compare the safety and effectiveness of Epi-OFF CXL treatment (performed using Ricrolin+ and VEGA UV-A system) compared to Epi-ON CXL (performed using Ricrolin+ and VEGA UV-A system) in eyes with keratoconus and other corneal ectatic disorders.Subjects will be randomized to receive the CXL treatment with either the Epi-On or Epi-Off technique.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be at least 12 years of age or older, male or female, of any race.
- •Having a diagnosis of keratoconus or other corneal ectatic disorder.
- •Presence of central or inferior steepening on the topography map.
- •Axial topography consistent with keratoconus or other corneal ectatic disorder.
- •For eyes diagnosed with keratoconus, presence of one or more slit lamp findings associated with keratoconus, such as:
- •Scissoring of the retinoscopic reflex
- •Fleischer ring
- •Vogt striae
- •Corneal thinning e .Corneal scarring
- •BSCVA 20/20 or worse.
- •Subject is willing to have CXL performed by the Epi-OFF or Epi-ON techniques.
- •Provide written informed consent and a signed HIPPA form. Pediatric subjects less than 14 years of age must sign an assent and a parent or legal guardian must sign an informed consent.
- •Willingness and ability to follow all instructions and comply with schedule for follow-up visits.
- •If female and capable of becoming pregnant, must not be lactating or pregnant and must agree to use a medically acceptable form of birth control for at least one week prior to the treatment visit and to continue o one month following treatment.
排除标准
- •One of the randomized CXL techniques (Epi-OFF or Epi-ON) is contraindicated or, in the investigator's clinical judgment, is not able to be performed in the study eye.
- •Study eye keratoconus severity is classified as being normal or atypical normal based on the OPD-Scan III keratoconus classification indices.
- •A history of previous corneal transplant in the study eye.
- •A history of prior CXL in the study eye.
- •Corneal pachymetry < 375 microns at the thinnest point as measured by ultrasound pachymetry in the study eye before epithelium removal. [NOTE: Eyes with corneal pachymetry between <375 microns and 325 microns may be enrolled in the compassionate use group.]
- •Presence of Intacs or corneal rings or segments in the study eye.
- •Previous ocular condition (other than refractive error) in the eye(s) to be treated that may predispose the eye for future complications or prevent the possibility of improved vision, for example:
- •History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- •Clinically significant corneal scarring in the treatment zone unrelated to keratoconus.
- •Eyes which are aphakic.
- •Eyes which are pseudophakic and do not have a UV blocking lens implanted.
- •A known contraindication, sensitivity, or allergy to the test article or its components or to study medications.
- •Nystagmus or any other condition that would prevent a steady gaze during the cross-linking treatment or other diagnostic tests.
- •If female, pregnant, nursing or planning a pregnancy, or having a positive urine pregnancy test prior to the randomization of, or treatment of, either eye during the course of the study.
- •A condition that, in the investigator's opinion, would interfere with or prolong epithelial healing, including a history of chemical injury or delayed epithelial healing in the study eye.
- •Presence or history or any other condition or finding that, in the investigator's opinion, makes the patient unsuitable as a candidate for cross-linking or study participation or may confound the outcome of the study.
研究组 & 干预措施
Epi-OFF CXL
The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.
干预措施: Ricrolin+ (Drug)
Epi-OFF CXL
The Epi-ON treatment will be performed without removal of the corneal epithelium. Ricrolin+will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-ON treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-ON treatment.
干预措施: VEGA UV-A system (Device)
Epi-ON CXL
The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.
干预措施: Ricrolin+ (Drug)
Epi-ON CXL
The Epi-OFF treatment will be performed with removal of the corneal epithelium before the first dose of riboflavin is administered. Ricrolin+ will be used as the riboflavin formulation for the pre-treatment and irradiation steps of the Epi-OFF treatments. The VEGA UV-A light will be used during the irradiation steps of the Epi-OFF treatment.
干预措施: VEGA UV-A system (Device)
结局指标
主要结局
Mean change in corneal curvature
时间窗: Baseline, 6 Months, and 12 Months
Percentage of eyes that had a greater than 2D increase in Kmax measured by the OPD-Scan III
次要结局
- Change in manifest refraction spherical equivalent(Baseline, 6 Months, and 12 Months)
- Change in best-corrected visual acuity (BSCVA)(Baseline, 6 Months, and 12 Months)
- Change in uncorrected-visual acuity (UCVA)(Baseline, 6 Months, and 12 Months)
- Change in thinnest pachymetry(Baseline, 6 Months, and 12 Months)