Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

Study Overview
=================
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.

Official Title
-----------------
the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts

Conditions
-----------------
Multifocal Contact Lenses

Intervention / Treatment
-----------------
* Device: short term Multifocal Contact Lenses
* Device: short term Bifocal Spectacles
* Device: long term Multifocal Contact Lenses
* Device: long term Bifocal Spectacles


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 7 Years
Maximum Age: 14 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: group A<br> | Device: short term Multifocal Contact Lenses<br>* wearing Multifocal Contact Lenses for one week<br>Device: short term Bifocal Spectacles<br>* wearing Bifocal Spectacles for one week<br>|
| Placebo Comparator: group B<br> | Device: short term Multifocal Contact Lenses<br>* wearing Multifocal Contact Lenses for one week<br>Device: short term Bifocal Spectacles<br>* wearing Bifocal Spectacles for one week<br>|
| Experimental: group C<br> | Device: long term Multifocal Contact Lenses<br>* wearing Multifocal Contact Lenses for one year<br>|
| Placebo Comparator: group D<br> | Device: long term Bifocal Spectacles<br>* wearing Bifocal Spectacles for one year<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demography (age, sex, laterality and medical history) | The demography of cataract and healthy children were recorded by using a semi-structured questionnaire. | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The refraction status (presented as spherical equivalent, SE) | Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists | after wearing contact lenses one month, three months ,six months and a year | 
| 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 | the feel of wearing during different daily activities | after wearing contact lenses one month, three months ,six months and a year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Multifocal Contact Lenses, Bifocal Spectacles, Congenital Cataracts