Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

NCT ID: NCT03260764

Last Updated: 2017-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-20

Study Completion Date

2017-12-31

Brief Summary

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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

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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.

Conditions

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Multifocal Contact Lenses

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group A

Group Type EXPERIMENTAL

short term Multifocal Contact Lenses

Intervention Type DEVICE

wearing Multifocal Contact Lenses for one week

short term Bifocal Spectacles

Intervention Type DEVICE

wearing Bifocal Spectacles for one week

group B

Group Type PLACEBO_COMPARATOR

short term Multifocal Contact Lenses

Intervention Type DEVICE

wearing Multifocal Contact Lenses for one week

short term Bifocal Spectacles

Intervention Type DEVICE

wearing Bifocal Spectacles for one week

group C

Group Type EXPERIMENTAL

long term Multifocal Contact Lenses

Intervention Type DEVICE

wearing Multifocal Contact Lenses for one year

group D

Group Type PLACEBO_COMPARATOR

long term Bifocal Spectacles

Intervention Type DEVICE

wearing Bifocal Spectacles for one year

Interventions

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short term Multifocal Contact Lenses

wearing Multifocal Contact Lenses for one week

Intervention Type DEVICE

short term Bifocal Spectacles

wearing Bifocal Spectacles for one week

Intervention Type DEVICE

long term Multifocal Contact Lenses

wearing Multifocal Contact Lenses for one year

Intervention Type DEVICE

long term Bifocal Spectacles

wearing Bifocal Spectacles for one year

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

7 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Haotian Lin

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Haotian Lin, M.D,Ph.D

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status

Countries

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China

Other Identifiers

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CCPMOH2017-China-7

Identifier Type: -

Identifier Source: org_study_id

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