Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

Not Applicable

• Conditions: Multifocal Contact Lenses
• Interventions: Device: short term Multifocal Contact Lenses; Device: long term Bifocal Spectacles; Device: long term Multifocal Contact Lenses; Device: short term Bifocal Spectacles

• Registration Number: NCT03260764
• Lead Sponsor: Sun Yat-sen University

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.

Study Timeline

• Status Verified: 2017-08
• Study Start: 2017-08-20
• Study First Submitted: 2017-08-22
• Study First Submitted QC: 2017-08-22
• Last Update Submitted: 2017-08-22
• Study First Posted: 2017-08-24
• Last Update Posted: 2017-08-24
• Primary Completion: 2017-12
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group A	short term Multifocal Contact Lenses	-
group B	short term Multifocal Contact Lenses	-
group B	short term Bifocal Spectacles	-
group D	long term Bifocal Spectacles	-
group A	short term Bifocal Spectacles	-
group C	long term Multifocal Contact Lenses	-

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
contrast sensitivity	after wearing contact lenses one month, three months ,six months and a year
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
questionnaire result	after wearing contact lenses one month, three months ,six months and a year	the feel of wearing during different daily activities
acuity	after wearing contact lenses one month, three months ,six months and a year

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China