NCT01845714已完成不适用
Impact of Keratoconus, Cross-linking and Cross-linking Combined With Topo-guided Photorefractive Keratectomy on Self-reported Quality of Life. A Three-year Update.
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Vision Specific quality of Life (VS-QoL)
研究概览
简要总结
Study Hypothesis: Former investigators indicated that keratoconus has a negative impact on vision-specific quality of life. This study attempts to confirm this statement and assess whether cross-linking and cross-linking combined with photorefractive keratectomy improve vision-specific quality of life, in a sample of keratoconus patients with 3-years follow-up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be diagnosed and classified as stage 1 keratoconus according to the Amsler-Krumeich classification system for keratoconus
- •present progressive keratoconus in consecutive corneal topographies, and/or changes in their refractive power.
- •Progressive keratoconus was defined when any of the following criteria was met for a period of 24 months:
- •an increase of 1.00 diopter (D) or more in the steepest keratometry measurement
- •an increase of 1.00 D or more in manifest cylinder
- •an increase of 0.50 D or more in manifest refraction spherical equivalent.
排除标准
- •suspicion for glaucoma
- •IOP-lowering medications
- •central corneal thickness (CCT) less than 400μm
- •K-readings more than 60D
- •history of herpetic keratitis
- •corneal scarring
- •severe eye dryness
- •pregnancy or nursing
- •current corneal infection
- •or underlying autoimmune disease KG members were further sub-divided into CxL and tCxL groups, according to their eligibility for treatment with CxL or CxL with tPRK. In order to be eligible for tCxL, group participants should, additionally, have CCT above 450μm.
结局指标
主要结局
Vision Specific quality of Life (VS-QoL)
时间窗: 3 years
次要结局
未报告次要终点
研究者
Georgios Labiris
Assistant Professor
Democritus University of Thrace
相似试验
已完成
不适用
Corneal Changes After Crosslinking in Keratoconus Patients Compared to the Untreated Fellow EyeKeratoconusNCT02428166Heidelberg University66
已完成
不适用
Correlation Between Eye Rubbing and Keratoconus Severity in a Treatment-naive Keratoconic PopulationKeratoconusNCT02883881Centre Hospitalier Régional Metz-Thionville33
已完成
不适用
Impact of corneal collagen cross-linking on vision-related quality of life in patients with progressive keratoconusH18.6KeratoconusDRKS00030330Augenklinik des Universitätsklinikums Hamburg-Eppendorf (UKE)41
已完成
不适用
Combined Corneal Wavefront-guided TPRK and ACXL Following ICRS Implantation in Management of Moderate KeratoconusKeratoconusNCT04383301Shaaban Elwan36
已完成
不适用
Validation Study on Eye Rubbing Questionnaire in Patients With or Suspected of Having a Keratoconus (KC)KeratoconusNCT04517903University Hospital, Bordeaux292