Congenital CataractNCT02040129
Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation in Congenital Cataract
A study testing Acrysof Toric IOL in people with Congenital Cataract, run by Kyungpook National University Hospital at 1 site in South Korea.
Trial summary
This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract. Read more about this study
- Who is it for?
- Ages 1 year to 13 years
- Conditions the study is for
- Congenital Cataract
- What is being tested?
- Acrysof Toric IOL
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2009to Nov 2009
- 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 1 year to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children less than 14 years
- Congenital cataract at initial visit
- Symmetrical keratometric astigmatism more than 2.0 D
Who cannot join
- Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age)
- Corneal pathology
- Keratoconus
- Irregular astigmatism
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract
This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.
Read the detailed description
This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.
- Conditions
- Congenital Cataract
- Being tested
- Acrysof Toric IOL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acrysof Toric IOLDevice
Lens implantation following cataract surgery
| Study group | Role | What they receive |
|---|---|---|
| Acrysof toric IOL | Experimental | Acrysof Toric intraocular lens in congenital cataract Receives: Device: Acrysof Toric IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in astigmatism after cataract surgery at 24 months
Measurement of refraction after cataract surgery was performed.
Measured: preop, 3,6,12,24 month postop
Secondary outcomes (1)
Change from baseline in quality of vision after cataract surgery at 24 months.
Measurement of visual acuity after cataract surgery was performed.
Measured: preop, 3,6,12,24 months postop
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2014 (estimated)
- Study startJan 2009
- Primary completionJan 2009
- Study completionNov 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital CataractStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyungpook National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bo Young Chun, Kyungpook National University Hospital
- Investigators
- Bo Young Chun, M.D, Principal investigator, Kyungpook National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02040129
- Sponsor's protocol ID
- KNUH2014-01
- Status last verified
- Jan 2014
- First submitted
- 16 Jan 2014
- Last updated
- 20 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Corneal Astigmatism With Toric Intraocular Lens Implantation : Early Results in Patients With Congenital Cataract
- ClinicalTrials.gov ID
- NCT02040129
- Acronym / sponsor ID
- KNUH2014-01
- Conditions
- Congenital Cataract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Kyungpook National University HospitalUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 20 Jan 2014 (estimated)
- 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.
This study was conducted to evaluate changes of reduction of corneal astigmatism with toric intraocular lens(IOL) in congenital cataract.
Detailed description
This retrospective study included 6 eyes from 4 patients (mean age 7.2 years) with congenital cataract who had an astigmatism of 2.5 to 4.0 D prior to cataract surgery. Review of preoperative and postoperative visual acuity (UCVA), refraction, toric axis was performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acrysof toric IOL | Experimental | Device: Acrysof Toric IOLAcrysof Toric intraocular lens in congenital cataract |
Who may qualify
- Ages
- 1 year to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children less than 14 years
- Congenital cataract at initial visit
- Symmetrical keratometric astigmatism more than 2.0 D
Key exclusion criteria (4 listed)
- Microcornea (horizontal corneal diameter less than 9.5mm-asper that particular age)
- Corneal pathology
- Keratoconus
- Irregular astigmatism
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 |
|---|---|---|
| Acrysof Toric IOLLens implantation following cataract surgery | Device | Acrysof toric IOL |
Primary outcome
Change from baseline in astigmatism after cataract surgery at 24 months
Time frame: preop, 3,6,12,24 month postop
Measurement of refraction after cataract surgery was performed.
1 secondary outcome
Change from baseline in quality of vision after cataract surgery at 24 months.
Time frame: preop, 3,6,12,24 months postop
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2014.
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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.
Bo Young Chun, M.D principal investigator
Kyungpook National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acrysof Toric IOL in people with Congenital Cataract, run by Kyungpook National University Hospital at 1 site in South Korea.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 20 Jan 2014. 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 South Korea. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline in astigmatism after cataract surgery at 24 months (time frame: preop, 3,6,12,24 month postop). 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 20 Jan 2014.