Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

August 22, 2017 updated by: Haotian Lin, Sun Yat-sen University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510060
        • Zhognshan Ophthalmic Center, Sun Yat-sen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 14 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Demography (age, sex, laterality and medical history)
Time Frame: baseline
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)
Time Frame: 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
after wearing contact lenses one month, three months ,six months and a year
acuity
Time Frame: after wearing contact lenses one month, three months ,six months and a year
after wearing contact lenses one month, three months ,six months and a year
contrast sensitivity
Time Frame: after wearing contact lenses one month, three months ,six months and a year
after wearing contact lenses one month, three months ,six months and a year
questionnaire result
Time Frame: after wearing contact lenses one month, three months ,six months and a year
the feel of wearing during different daily activities
after wearing contact lenses one month, three months ,six months and a year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sun Yat-sen University

Investigators

  • Principal Investigator: Haotian Lin, M.D,Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2017

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

August 22, 2017

First Submitted That Met QC Criteria

August 22, 2017

First Posted (Actual)

August 24, 2017

Study Record Updates

Last Update Posted (Actual)

August 24, 2017

Last Update Submitted That Met QC Criteria

August 22, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCPMOH2017-China-7

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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