Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts

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: Multifocal Contact Lenses
• Intervention / Treatment: Device: short term Multifocal Contact Lenses; Device: short term Bifocal Spectacles; Device: long term Multifocal Contact Lenses; Device: long term 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.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

4

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)	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)	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		after wearing contact lenses one month, three months ,six months and a year
contrast sensitivity		after wearing contact lenses one month, three months ,six months and a year
questionnaire result	the feel of wearing during different daily activities	after wearing contact lenses one month, three months ,six months and a year

Collaborators and Investigators

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

Study record dates

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: Congenital Cataracts; Multifocal Contact Lenses; Bifocal Spectacles
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• 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