Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 604
- 试验地点
- 1
- 主要终点
- Change of best corrected visual acuity
研究概览
简要总结
This is a single-centre, observational cohort study with the following objectives: Firstly, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients. Secondly, the investigators target to investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis. Thirdly, to explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis. Lastly, this study aims to explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.
详细描述
Congenital ectopia lens is a rare ophthalmic disease that seriously harms the physical and mental health of patients. Surgery is the only definite treatment at present. However, the changes in vision-related quality of life, mental health status, ocular biological parameters postoperative congenital dislocation of lens have not been systematically studied in the Chinese population.
In this trial, the investigators aim to evaluate the vision-related quality of life and mental health status in congenital ectopia lentis patients, investigate the correlations between genotype and clinical phenotype in patients of congenital ectopia lentis, explore the metabolic profiles in the aqueous humor (AH) of patients with congenital ectopia lentis, and explore the longitudinal changes of ocular biological parameters and complications in patients with postoperative congenital ectopia lens in the Chinese population.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Diagnosed with congenital lens dislocation and age ≥ 3 years old.
- •Agree to participate in this study with written informed consent from patients or legal guardians.
排除标准
- •History of ophthalmic trauma or other ophthalmic surgeries.
- •Combined with other ophthalmic diseases such as primary glaucoma, uveitis and corneal disease.
- •Patients who could not cooperate in the examinations.
结局指标
主要结局
Change of best corrected visual acuity
时间窗: Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation
Best corrected visual acuity (BCVA) is evaluated with an ETDRS chart at each visit.
Incidence of complications
时间窗: Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation.
Estimate the incidence of complications for both non-surgical group and surgical group.
次要结局
- Change of axial length(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation.)
- Anterior chamber angle.(Non-surgical group is assessed at first visit, and 1, 2, 3 years after enrollment. Surgical group will be assessed preoperation, 3 months, and 1, 2, 3 years postoperation.)
- Tilt and eccentricity of intraocular lens(3 months, and 1, 2, 3 years postoperation)
- Aortic root diameter(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation)
- Vision-related quality of life(Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.)
- High order aberrations(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation)
- The state of zonules(Non-surgical group is assessed at first visit, and 1, 2, 3 years after enrollment. Surgical group will be assessed preoperation.)
- Body mass index (BMI)(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.)
- Metacarpophalangeal joint length(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation.)
- Central cornea endothelial cell loss(Preoperation, and 3 months, and 1, 2, 3 years postoperation)
- Intraocular pressure(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation, 3 months, and 1, 2, 3 years postoperation.)
- Aortic Root (Sinuses of Valsalva) Z-score, adjusted by body-surface-area (Z-score)(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation)
- Incidence of valvular heart disease(Non-surgical group is evaluated at first visit, and 1, 2, 3 years after enrollment. Surgical group is evaluated at preoperation and 1, 2, 3 years postoperation)
- Choriocapillaris flow deficits(Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.)
- Genetic mutation state of patients(Preoperation)
- Choroidal thickness(Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.)