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Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

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ClinicalTrials.gov Identifier: NCT03260764
Recruitment Status : Unknown
Verified August 2017 by Haotian Lin, Sun Yat-sen University.
Recruitment status was:  Active, not recruiting
First Posted : August 24, 2017
Last Update Posted : August 24, 2017
Sponsor:
Information provided by (Responsible Party):
Haotian Lin, 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.

Condition or disease Intervention/treatment Phase
Multifocal Contact Lenses Device: short term Multifocal Contact Lenses Device: short term Bifocal Spectacles Device: long term Multifocal Contact Lenses Device: long term Bifocal Spectacles Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts
Actual Study Start Date : August 20, 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract Eye Wear

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

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

Experimental: group C Device: long term Multifocal Contact Lenses
wearing Multifocal Contact Lenses for one year

Placebo Comparator: group D Device: long term Bifocal Spectacles
wearing Bifocal Spectacles for one year




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. acuity [ Time Frame: after wearing contact lenses one month, three months ,six months and a year ]
  3. contrast sensitivity [ Time Frame: after wearing contact lenses one month, three months ,six months and a year ]
  4. 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



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Ages Eligible for Study:   7 Years to 14 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03260764


Locations
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China, Guangdong
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, China, 510060
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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Principal Investigator: Haotian Lin, M.D,Ph.D Zhongshan Ophthalmic Center, Sun Yat-sen University

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Responsible Party: Haotian Lin, Clinical Professor, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03260764     History of Changes
Other Study ID Numbers: CCPMOH2017-China-7
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: August 24, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Haotian Lin, Sun Yat-sen University:
Multifocal Contact Lenses
Bifocal Spectacles
Congenital Cataracts
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases