Multifocal Contact Lenses
Conditions
Keywords
Multifocal Contact Lenses, Bifocal Spectacles, Congenital Cataracts
Brief summary
In this study, the investigators provide participants who had congenital cataract the multifocal contact lenses and bifocal spectacles in the purpose of seeking out a better way to make a definite diagnosis with high efficiency and accuracy, and report a prospective, randomized controlled study aiming at comparison of multifocal contact lenses and bifocal spectacles.
Detailed description
Children diagnosed as cataract without treatment were enrolled to a prospective, randomized controlled study. Patients were assigned to four groups: participants in group A wearing multifocal contact lenses a week and then bifocal spectacles a week;in Group B, the participants wearing bifocal spectacles a week and then multifocal contact lenses;in Group C, the participants wearing multifocal contact lenses four a year;in Group D, the participants wearing bifocal spectacles four a year. Investigators compare the acuity, refraction, contrast sensitivity and the results of questionnaire between A and B , C and D groups.
Interventions
DEVICEshort term Multifocal Contact Lenses
wearing Multifocal Contact Lenses for one week
DEVICEshort term Bifocal Spectacles
wearing Bifocal Spectacles for one week
DEVICElong term Multifocal Contact Lenses
wearing Multifocal Contact Lenses for one year
DEVICElong term Bifocal Spectacles
wearing Bifocal Spectacles for one year
Sponsors
Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* diagnosed as binocular cataract * after the surgery of binocular intraocular lens implantation more than one month
Exclusion criteria
* diagnosed as xerophthalmus * diagnosed as other eye diseases or systemic diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demography (age, sex, laterality and medical history) | baseline | The demography of cataract and healthy children were recorded by using a semi-structured questionnaire. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The refraction status (presented as spherical equivalent, SE) | after wearing contact lenses one month, three months ,six months and a year | Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists |
| acuity | after wearing contact lenses one month, three months ,six months and a year | — |
| contrast sensitivity | after wearing contact lenses one month, three months ,six months and a year | — |
| questionnaire result | after wearing contact lenses one month, three months ,six months and a year | the feel of wearing during different daily activities |
Countries
China
Outcome results
None listed