Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

Multifocal Contact Lenses Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03260764
• Other study ID #: CCPMOH2017-China-7
• Status: Active, not recruiting
• Phase: N/A
• First received: August 22, 2017
• Last updated: August 22, 2017
• Start date: August 20, 2017
• Est. completion date: December 2017

Study information

• Verified date: August 2017
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Multifocal Contact Lenses

Intervention

Device:
• short term Multifocal Contact Lenses
wearing Multifocal Contact Lenses for one week
• short term Bifocal Spectacles
wearing Bifocal Spectacles for one week
• long term Multifocal Contact Lenses
wearing Multifocal Contact Lenses for one year
• long term Bifocal Spectacles
wearing Bifocal Spectacles for one year

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demography (age, sex, laterality and medical history)	The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.	baseline
Secondary	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
Secondary	acuity		after wearing contact lenses one month, three months ,six months and a year
Secondary	contrast sensitivity		after wearing contact lenses one month, three months ,six months and a year
Secondary	questionnaire result	the feel of wearing during different daily activities	after wearing contact lenses one month, three months ,six months and a year