Optical Coherence Tomography-Aided Differential Diagnosis and Treatment of Irregular Corneas
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 445
- 试验地点
- 1
- 主要终点
- Develop OCT metrics for more sensitive detection of keratoconus progression
研究概览
简要总结
This main goal of this study is to improve the detection, classification, monitoring, and treatment of irregular corneas due to keratoconus, warpage, dry eye, scar, stromal dystrophies, and other corneal conditions.
The primary goal will be achieved by using optical coherence tomography (OCT) to:
- Develop an OCT-based system to classify and evaluate corneal-shape irregularities.
- Develop OCT metrics for more sensitive detection of keratoconus progression.
- Develop OCT-and-topography guided phototherapeutic keratectomy (PTK) for irregular corneas.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 14 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Keratoconus:
- •CDVA ≥ 20/25 in the better eye; and both of the following in the worse eye
- •Topography characteristic of keratoconus or pellucid marginal degeneration
- •Contact lens-related corneal warpage:
- •Contact lens use; and
- •Topography irregularities
- •Symptoms of dry eye documented by Ocular Surface Disease Index (OSDI) questionnaire score ≥ 30; and
- •Topography irregularities
- •Presence of punctate epithelial erosion on exam with surface staining
- •Aqueous deficiency or evaporative dry eye
- •Epithelial basement membrane dystrophy (EBMD):
- •Negative corneal fluorescein staining; and
- •Corneal opacities; and
- •Topography irregularities
- •Stromal addition or subtraction:
- •Salzmann's degeneration; or
- •Stromal dystrophies; or
- •Complication (visual complaints) after LASIK or photorefractive keratectomy (PRK)
- •Stromal distortion:
- •Radial keratectomy (RK); or
- •Corneal transplants.
- •Normal controls:
- •Healthy eyes with no previous eye procedures/surgeries.
- •Participants will be selected from the keratoconus population in Group A based on topography findings.
- •Participants will be selected from the stromal addition/subtraction and stromal distortion populations of Group A if they have vision primarily limited by scars, dystrophy, or high astigmatism that could benefit from PTK.
- •Exclusion Criteria (all groups):
- •Inability to give informed consent.
- •Inability to maintain fixation for OCT imaging.
- •Inability to commit to required study visits.
- •Eyes with concurrent cataract, retinal disease, glaucoma, or other eye conditions that may limit the visual outcome after surgery.
- •Previous corneal surgeries if considered as a keratoconus participant.
- •Pregnancy or breastfeeding.
排除标准
- 未提供
结局指标
主要结局
Develop OCT metrics for more sensitive detection of keratoconus progression
时间窗: 4 year
Secondary measurement will be OCT corneal shape assessed in Diopter units.
Develop OCT- and topography-guided phototherapeutic keratectomy (PTK) for irregular corneas
时间窗: 1 year
The secondary goal is to improve the post-procedural outcome of refractive error. This will be measured in Diopter units.
Develop OCT-based system to classify and evaluate corneal-shape irregularities
时间窗: 1 day
Secondary measurement will be OCT corneal shape assessed in Diopter units.
次要结局
未报告次要终点
研究者
David Huang
Yan Li, PhD, Assistant Professor of Ophthalmology
Oregon Health and Science University