The Cohort Study of Pediatric Cataract
ConditionPediatric Cataract
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University
About this trial
This retrospective-prospective bidirectional cohort study aims to observe ocular parameter changes, different surgical/vision recovery strategies and postoperative adverse effects among young children with cataract. The influence on psychology and cognitive function will be taken into consideration as well.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
aged < 18 yo at the 1st visit unilateral or bilateral cataract agree to participant in this study and sign the informed consent
Disqualifiers
adults
Trial population
This is a retrospective-prospective bidirectional cohort study. Patients aged \< 18 yo at the 1st visit are enrolled.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Best-corrected visual acuity changes
Best-corrected visual acuity changes are measured by visual acuity charts (Teller/Lea symbol/ETDRS chart) every 1 year at scheduled time
Time frame
Baseline and through study completion, an average of 1 year2
Intraocular pressure changes
Intraocular pressures are measured by NCT machine
Time frame
Baseline and through study completion, an average of 1 year3
Refractive power changes
Refractive power are measured at baseline and every visit at least every 1 year
Time frame
Baseline and through study completion, an average of 1 year4
Ocular biological measurements changes
Ocular biological measurements including axial length, corneal keratometry, anterior chamber angle/depth, corneal endothelial cell number and appearance
Time frame
Baseline and through study completion, an average of 1 yearSecondary outcomes
1
Other factors changes
Sleep, depression, cognitive function are measured by questionnaires. Self-Rating Scale of Sleep: minimum value-1 point, maximum value-50, and higher scores mean worse outcome. Hamilton Depression Scale: \<7 points-normal, and higher scores mean worse outcome. Loewenstein Cognitive Assessment: for every question, minimum 1 point, and maximum 4 points. Higher scores mean worse outcomes.
Time frame
Baseline and through study completion, an average of 1 year2
BMI changes
BMI is measured by technicians in every visit
Time frame
Baseline and through study completion, an average of 1 year3
Blood pressure changes
Diastolic and systolic blood pressure are measured by technicians in every visit
Time frame
Baseline and through study completion, an average of 1 year4
Stereopsis changes
Stereopsis is measured by Randot Stereotest
Time frame
Baseline and through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov