Back to resultsMultifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts
Primary Purpose
Multifocal Contact Lenses
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
short term Multifocal Contact Lenses
short term Bifocal Spectacles
long term Multifocal Contact Lenses
long term Bifocal Spectacles
Sponsored by
About this trial
This is an interventional treatment trial for Multifocal Contact Lenses focused on measuring Multifocal Contact Lenses, Bifocal Spectacles, Congenital Cataracts
Eligibility 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
Sites / Locations
- Zhognshan Ophthalmic Center, Sun Yat-sen University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Placebo Comparator
Experimental
Placebo Comparator
Arm Label
group A
group B
group C
group D
Arm Description
Outcomes
Primary Outcome Measures
Demography (age, sex, laterality and medical history)
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.
Secondary Outcome Measures
The refraction status (presented as spherical equivalent, SE)
Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists
acuity
contrast sensitivity
questionnaire result
the feel of wearing during different daily activities
Full Information
NCT ID
NCT03260764
First Posted
August 22, 2017
Last Updated
August 22, 2017
Sponsor
Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT03260764
Brief Title
Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts
Official Title
the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 20, 2017 (Actual)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multifocal Contact Lenses
Keywords
Multifocal Contact Lenses, Bifocal Spectacles, Congenital Cataracts
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group A
Arm Type
Experimental
Arm Title
group B
Arm Type
Placebo Comparator
Arm Title
group C
Arm Type
Experimental
Arm Title
group D
Arm Type
Placebo Comparator
Intervention Type
Device
Intervention Name(s)
short term Multifocal Contact Lenses
Intervention Description
wearing Multifocal Contact Lenses for one week
Intervention Type
Device
Intervention Name(s)
short term Bifocal Spectacles
Intervention Description
wearing Bifocal Spectacles for one week
Intervention Type
Device
Intervention Name(s)
long term Multifocal Contact Lenses
Intervention Description
wearing Multifocal Contact Lenses for one year
Intervention Type
Device
Intervention Name(s)
long term Bifocal Spectacles
Intervention Description
wearing Bifocal Spectacles for one year
Primary Outcome Measure Information:
Title
Demography (age, sex, laterality and medical history)
Description
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.
Time Frame
baseline
Secondary Outcome Measure Information:
Title
The refraction status (presented as spherical equivalent, SE)
Description
Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists
Time Frame
after wearing contact lenses one month, three months ,six months and a year
Title
acuity
Time Frame
after wearing contact lenses one month, three months ,six months and a year
Title
contrast sensitivity
Time Frame
after wearing contact lenses one month, three months ,six months and a year
Title
questionnaire result
Description
the feel of wearing during different daily activities
Time Frame
after wearing contact lenses one month, three months ,six months and a year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haotian Lin, M.D,Ph.D
Organizational Affiliation
Zhongshan Ophthalmic Center, Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Zhognshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510060
Country
China
12. IPD Sharing Statement
Learn more about this trial
Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts
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