CataractNCT03242486
Clinical Evaluation of Toric Intraocular Lens
A study testing toric intraocular lens in people with Cataract and Astigmatism, run by Nidek Co. LTD..
Trial summary
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Cataract, Astigmatism
- What is being tested?
- toric intraocular lens
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- Dec 2014to 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with age of 40 years or older
- Patients with age-related cataract in one eye or both eyes.
- Patients willing to participate in the required postoperative study.
- Patient who can understand and sign the consent document.
- An eye whose pupil diameter after mydriasis is 5 mm or greater.
- An eye whose preoperative corneal cylindrical power is 1.0D or more.
- An eye whose postoperative astigmatism is predicted to be less than 0.5 D.
- An eye whose postoperative visual acuity with spherical addition is 0.8 D or more.
Who cannot join
- Disorder of corneal endothelium
- Uncontrolled glaucoma
- Active Uveitis
- Diabetic retinopathy
- Retinal detachment
- Congenital ocular anomalies
Show all 29Show fewer
- Choroidal hemorrhage
- Shallow anterior chamber
- Microphthalmus
- Corneal dystrophy
- Optic atrophy
- Ocular hypertension
- Amblyopia
- Previous history of corneal transplantation
- Active Iritis
- Corneal disorder
- Macular degeneration
- Retinal degeneration
- Clinically significant change in macula and/or retinal pigment epithelium
- Corneal irregular astigmatism
- Atopic disease
- Brittleness of Zinn's zonule, fractured zonule and lens luxation (including subluxation)
- Pseudo-exfoliation syndrome
- Iris neovascularization
- Long axis length eye (axis length : 28mm or more)
- Severe dry eye, abnormality of the lens surface
- Concurrent participation in another drug and device clinical investigation
- Patient with mental deficiency or psychiatric disorder and/or who is not capable of expressing the consent of participating in the trial
- Patient who is judged inappropriate by investigators or sub-investigators
About this study
Official title: Safety and Effectiveness Evaluation of Toric Intraocular Lens
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
Read the detailed description
Effectiveness
- primary endpoint is visual acuity with pre-determined spherical correction.
- secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation
Safety
- number and percentage of adverse event
- Conditions
- Cataract, Astigmatism
- Being tested
- toric intraocular lens
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
toric intraocular lensDevice
| Study group | Role | What they receive |
|---|---|---|
| toric intraocular lens | Experimental | toric intraocular lens is implanted to all subjects Receives: Device: toric intraocular lens |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
Visual acuity with pre-determined spherical correction
Measured: postoperative 6 months
Secondary outcomes (2)
Visual acuity
UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent
Measured: postoperative 6 months
IOL rotation
angle of rotation
Measured: postoperative 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2017
- Study startDec 2014
- Primary completionMay 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nidek Co. LTD.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03242486
- Sponsor's protocol ID
- TIOL-YST
- Status last verified
- Feb 2018
- First submitted
- 16 Jun 2017
- Last updated
- 20 Feb 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sugita I, Ogawa T, Ichikawa K, Okita T, Negishi K, Nakano T, Tsuneoka H. Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics. BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.
PubMed 35033047
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness Evaluation of Toric Intraocular Lens
- ClinicalTrials.gov ID
- NCT03242486
- Acronym / sponsor ID
- TIOL-YST
- Conditions
- Cataract, Astigmatism
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Nidek Co. LTD.Industry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 8 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.
Evaluate efficacy and safety of the toric IOL implanted into aphakic eye with corneal astigmatism after cataract surgery.
Detailed description
Effectiveness
- primary endpoint is visual acuity with pre-determined spherical correction.
- secondary endpoint is UCVA with spherical correction, BSCVA, Refractive Cylinder Correction, Spherical Equivalent, IOL rotation
Safety
- number and percentage of adverse event
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| toric intraocular lens | Experimental | Device: toric intraocular lenstoric intraocular lens is implanted to all subjects |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients with age of 40 years or older
- Patients with age-related cataract in one eye or both eyes.
- Patients willing to participate in the required postoperative study.
- Patient who can understand and sign the consent document.
- An eye whose pupil diameter after mydriasis is 5 mm or greater.
Key exclusion criteria (29 listed)
- Disorder of corneal endothelium
- Uncontrolled glaucoma
- Active Uveitis
- Diabetic retinopathy
- Retinal detachment
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 |
|---|---|---|
| toric intraocular lens | Device | toric intraocular lens |
Primary outcome
Visual acuity
Time frame: postoperative 6 months
Visual acuity with pre-determined spherical correction
2 secondary outcomes
Visual acuity
Time frame: postoperative 6 months
IOL rotation
Time frame: postoperative 6 months
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 Feb 2018.
- Derived from this study: PubMed 35033047Sugita I, Ogawa T, Ichikawa K, Okita T, Negishi K, Nakano T, Tsuneoka H. Rotational stability and clinical outcomes of a new one piece toric intraocular lens with anchor-wing haptics. BMC Ophthalmol. 2022 Jan 15;22(1):26. doi: 10.1186/s12886-021-02240-7.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing toric intraocular lens in people with Cataract and Astigmatism, run by Nidek Co. LTD..
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 8 inclusion and 29 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 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Visual acuity (time frame: postoperative 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03242486, which also lists 1 linked publication.
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 Feb 2018.