Multifocal Contact LensesNCT03260764
Multifocal Contact Lenses vs Bifocal Spectacles for Congenital Cataracts
A study testing short term Multifocal Contact Lenses, short term Bifocal Spectacles and long term Multifocal Contact Lenses in people with Multifocal Contact Lenses, run by Sun Yat-sen University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Multifocal Contact Lenses
- What is being tested?
- short term Multifocal Contact Lenses, short term Bifocal Spectacles and long term Multifocal Contact Lenses
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2017to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- diagnosed as binocular cataract
- after the surgery of binocular intraocular lens implantation more than one month
Who cannot join
- diagnosed as xerophthalmus
- diagnosed as other eye diseases or systemic diseases
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
Official title: 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.
Read the 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.
- Conditions
- Multifocal Contact Lenses
- Being tested
- short term Multifocal Contact Lenses, short term Bifocal Spectacles, long term Multifocal Contact Lenses, long term Bifocal Spectacles
- Keywords
- Multifocal Contact Lenses, Bifocal Spectacles, Congenital Cataracts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
short term Multifocal Contact LensesDevice
wearing Multifocal Contact Lenses for one week
short term Bifocal SpectaclesDevice
wearing Bifocal Spectacles for one week
long term Multifocal Contact LensesDevice
wearing Multifocal Contact Lenses for one year
long term Bifocal SpectaclesDevice
wearing Bifocal Spectacles for one year
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Not described Receives: Device: short term Multifocal Contact Lenses; Device: short term Bifocal Spectacles |
| group B | Placebo comparator | Not described Receives: Device: short term Multifocal Contact Lenses; Device: short term Bifocal Spectacles |
| group C | Experimental | Not described Receives: Device: long term Multifocal Contact Lenses |
| group D | Placebo comparator | Not described Receives: Device: long term Bifocal Spectacles |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demography (age, sex, laterality and medical history)
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.
Measured: baseline
Secondary outcomes (4)
The refraction status (presented as spherical equivalent, SE)
Refractions were conducted with objective retinoscopy and cycloplegia, and performed by experienced optometrists
Measured: after wearing contact lenses one month, three months ,six months and a year
acuity
Measured: after wearing contact lenses one month, three months ,six months and a year
contrast sensitivity
Measured: after wearing contact lenses one month, three months ,six months and a year
questionnaire result
the feel of wearing during different daily activities
Measured: after wearing contact lenses one month, three months ,six months and a year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start20 Aug 2017
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multifocal Contact LensesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D,Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03260764
- Sponsor's protocol ID
- CCPMOH2017-China-7
- Status last verified
- Aug 2017
- First submitted
- 22 Aug 2017
- Last updated
- 24 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- the Comparison of Multifocal Contact Lenses and Bifocal Spectacles for Congenital Cataracts
- ClinicalTrials.gov ID
- NCT03260764
- Acronym / sponsor ID
- CCPMOH2017-China-7
- Conditions
- Multifocal Contact Lenses
- Keywords
- Multifocal Contact Lenses, Bifocal Spectacles, Congenital Cataracts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 20 Aug 2017 (actual)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Device: short term Multifocal Contact Lenses, Device: short term Bifocal Spectacles |
| group B | Placebo comparator | Device: short term Multifocal Contact Lenses, Device: short term Bifocal Spectacles |
| group C | Experimental | Device: long term Multifocal Contact Lenses |
| group D | Placebo comparator | Device: long term Bifocal Spectacles |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- diagnosed as binocular cataract
- after the surgery of binocular intraocular lens implantation more than one month
Key exclusion criteria (2 listed)
- diagnosed as xerophthalmus
- diagnosed as other eye diseases or systemic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| short term Multifocal Contact Lenseswearing Multifocal Contact Lenses for one week | Device | group A, group B |
| short term Bifocal Spectacleswearing Bifocal Spectacles for one week | Device | group A, group B |
| long term Multifocal Contact Lenseswearing Multifocal Contact Lenses for one year | Device | group C |
| long term Bifocal Spectacleswearing Bifocal Spectacles for one year | Device | group D |
Primary outcome
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.
4 secondary outcomes
The refraction status (presented as spherical equivalent, SE)
Time frame: 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
contrast sensitivity
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Haotian Lin, M.D,Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing short term Multifocal Contact Lenses, short term Bifocal Spectacles and long term Multifocal Contact Lenses in people with Multifocal Contact Lenses, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demography (age, sex, laterality and medical history) (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2017.