NCT Number: NCT05654025
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.
Interested in participating?
Request Info3 year and older
All sexes
Observational
Guangzhou, Guangdong, 510060, China
Location status: Recruiting
Dangying Zheng, MD
PRINCIPAL_INVESTIGATOR
Yizhi Liu, PhD
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 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.
Time frame: 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.
Time frame: 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.
Axial length will be evaluated with ZEISS IOLMaster 700 at each visit.
Time frame: 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
High order aberrations will be assessed with Nidek OPD-Scan III at each visit.
Time frame: Preoperation, and 3 months, and 1, 2, 3 years postoperation
Central cornea endothelial cell loss will be calculated with endokeratoscope in surgical group.
Time frame: Non-surgical group is assessed at first visit, and 1, 2, 3 years after enrollment. Surgical group will be assessed preoperation.
The state of zonules will be assessed using ultrasound biomicroscopy.
Time frame: 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.
Anterior chamber angle will be assessed using Tomey Casia 2 anterior segment optical coherence tomography (OCT).
Time frame: 3 months, and 1, 2, 3 years postoperation
Tilt and eccentricity of intraocular lens was evaluated with Pentacam in surgical group.
Time frame: 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.
Intraocular pressure with non-contact-tonometer at each visit.
Time frame: 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
Aortic root diameter will be measured using echocardiography.
Time frame: 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
Z-Score will be calculated using the Marfan foundation's calculator (https://marfan.org/dx/zscore-children/). Normal Z-score range from -2 to 2. A dilated aortic root is defined as a Z-score ≥2.0. A larger Z-score is associated with an increased risk of aortic complications such as dissection, rupture, and valvular regurgitation.
Time frame: 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
The incidence of valvular heart disease (VHD) is defined as the ratio of patients diagnosed with VHD to the total number of patients enrolled.
Time frame: 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.
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. The normal range for the Chinese population is 18.5 to 23.9. A high BMI can indicate high body fatness.
Time frame: 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 will be measured using palmar radiograph.
Time frame: Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.
Choroidal thickness will be measured with optical coherence tomography (OCT) images.
Time frame: Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.
Choriocapillaris flow deficits will be measured with optical coherence tomography angiography (OCTA) images.
Time frame: Preoperation
Draw blood to detect the exact gene mutations in patients via whole-exome sequencing.
Time frame: Non-surgical group is evaluated at first visit and 3 years after enrollment. Surgical group is evaluated at preoperation and 3 years postoperation.
Vision-related quality of life will be assessed with the Pediatric Eye Questionnaire (PedEyeQ).
Contact information is provided by the study sponsor or research team.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Other
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07096622
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Guangzhou, Guangdong, China
View Trial DetailsNCT05628129
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Guangzhou, Guangdong, China
View Trial DetailsNCT04319107
Abnormalities, Multiple, Bone Diseases
Bron, France
View Trial DetailsNCT07257172
Eye Diseases, Lens Diseases
Warsaw, Masovian Voivodeship, Poland
View Trial Details