Clinical trial NCT05654025: Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens
Official title: Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ectopia Lentis
Dislocation, Lens
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-12-16
Enrollment: 604
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients diagnosed with congenital ectopia lentis at Zhongshan ophthalmic center.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change of best corrected visual acuity
timeFrame: 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
measure: Incidence of complications
timeFrame: 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.
Secondary outcomes:
measure: Change of axial length
timeFrame: 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.
measure: High order aberrations
timeFrame: 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
measure: Central cornea endothelial cell loss
timeFrame: Preoperation, and 3 months, and 1, 2, 3 years postoperation
measure: The state of zonules
timeFrame: Non-surgical group is assessed at first visit, and 1, 2, 3 years after enrollment. Surgical group will be assessed preoperation.
measure: Anterior chamber angle.
timeFrame: 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.
measure: Tilt and eccentricity of intraocular lens
timeFrame: 3 months, and 1, 2, 3 years postoperation
measure: Intraocular pressure
timeFrame: 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.
measure: Aortic root diameter
timeFrame: 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
measure: Aortic Root (Sinuses of Valsalva) Z-score, adjusted by body-surface-area (Z-score)
timeFrame: 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
measure: Incidence of valvular heart disease
timeFrame: 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
measure: Body mass index (BMI)
timeFrame: 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.
measure: Metacarpophalangeal joint length
timeFrame: 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.
measure: Choroidal thickness
timeFrame: Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.
measure: Choriocapillaris flow deficits
timeFrame: Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.
measure: Genetic mutation state of patients
timeFrame: Preoperation
measure: Vision-related quality of life
timeFrame: Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial Clinical Research Center for Ocular Diseases, State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-sen University, Guangdong Provincial Key Laboratory of Ophthalmology and Visual Science
state: Guangdong
Study officials:
affiliation: Guangdong Provincial Clinical Research Center for Ocular Diseases
name: Danying Zheng
role: PRINCIPAL_INVESTIGATOR
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