Shanghai High Myopia Study
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-100
SponsorShanghai High Myopia Study Group
About this trial
The purpose of this study is to evaluate the long-term visual outcome of the cataract surgery using a large-scale and comprehensive database of high myopic cataract and age-related cataract patients. The investigators will further investigate into the various genetic and environmental factors that may contribute to the pathogenesis of high myopic cataract.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Clinical diagnosis of cataract
Must be able to cooperate with the ophthalmic examination
Disqualifiers
Clinical diagnosis of mental illness
Mentally disabled
Trial population
Cataract patients who will undergo cataract surgery in Eye and ENT Hospital of Fudan University.
Trial design
Design model
Other
Time perspective
Prospective
Treatments tested in this trial
Cataract
Other interventionThe genetic and environmental factors concerning to the pathogenesis of cataract in the three groups.
Treatment groups
60,000 Participants
are divided into 3 treatment groupsGroup A: High myopic cataract group1 intervention
Group B: Age-related cataract group1 intervention
Group C: Ametropic cataract group1 intervention
Trial outcomes
Primary outcomes
1
Differences in the clinical phenotypes and visual outcomes of high myopic cataract patients
Cataract type and severity of high myopic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Time frame
Follow-up until five years after surgery2
Differences in the clinical phenotypes and visual outcomes of age-related cataract patients
Cataract type and severity of age-related cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Time frame
Follow-up until five years after surgery3
Differences in the clinical phenotypes and visual outcomes of ametropic cataract patients
Cataract type and severity of ametropic cataract patients are evaluated using LOCSIII grading system. Visual outcomes are also evaluated including visual acuity with or without correction, intraocular pressure, fundus function, contrast sensitivity and other visual outcome measurements.
Time frame
Follow-up until five years after surgerySecondary outcomes
1
Genetic diversity based on biological specimen samples of three groups
Sequencing of selected genes (including exons, promoters, 5' UTR and 3' UTR sequences) on a large scale to intensively investigate into the sites and functions of single nucleotide polymorphism (SNP) correlated with clinical features of HMC, compared to age-related cataract and ametropic cataract patients.
Time frame
Analyzed within six months after surgeryOther outcomes
1
Difference in the surgical procedure of three groups
To compare the difference in the surgical procedure of three groups.
Time frame
Recorded on the surgery day for further analysis2
Difference in the Diagnostic test of three groups
To compare the difference in the diagnostic test of three groups.
Time frame
Recorded before the surgery day for further analysis3
Difference in the complications of the cataract surgery of three groups
To compare the prevalence of complications of the cataract surgery in HMC,ARC and ametropic cataract patients.
Time frame
Follow-up until five years after surgerySponsors and contacts
Click on the lead sponsor to view all of their trials.
Shanghai High Myopia Study Group
Lead sponsor
Eye & ENT Hospital of Fudan University
Collaborator
Source ClinicalTrials.gov