Follow up Study on Visual Prognosis and Complications of Ectopia Lentis Lens
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age3+
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
All patients diagnosed with congenital ectopia lentis at Zhongshan ophthalmic center.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
604 Participants
are grouped into 2 trial groupsGroup A: Non-surgical group: Refractive change, ocular parameter changes, and prognosis without surgery
Group B: Surgical group: Safety and efficacy of different congenital ectopia lentis surgeries
Trial outcomes
Primary outcomes
1
Change of best corrected visual acuity
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 postoperation2
Incidence of complications
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.Secondary outcomes
1
Change of axial length
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.2
High order aberrations
High order aberrations will be assessed with Nidek OPD-Scan III 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 postoperation3
Central cornea endothelial cell loss
Central cornea endothelial cell loss will be calculated with endokeratoscope in surgical group.
Time frame
Preoperation, and 3 months, and 1, 2, 3 years postoperation4
The state of zonules
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.Sponsors and contacts
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Source ClinicalTrials.gov