Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

Sun Yat-sen University

Status: Unknown

Conditions: Multifocal Contact Lenses

Treatments: Device: short term Multifocal Contact Lenses; Device: short term Bifocal Spectacles; Device: long term Bifocal Spectacles; Device: long term Multifocal Contact Lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT03260764

CCPMOH2017-China-7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 7 to 14 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 4 patient groups, including a placebo group

group A

Experimental group

Treatment:

Device: short term Bifocal Spectacles

Device: short term Multifocal Contact Lenses

group B

Placebo Comparator group

Treatment:

Device: short term Bifocal Spectacles

Device: short term Multifocal Contact Lenses

group C

Experimental group

Treatment:

Device: long term Multifocal Contact Lenses

group D

Placebo Comparator group

Treatment:

Device: long term Bifocal Spectacles