AstigmatismNCT03085901

Comparison of Clinical Outcomes of Toric Intraocular Lens

A study testing Precizon toric intraocular lens and Tecnis toric intraocular lens in people with Astigmatism, run by Samsung Medical Center.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL. Read more about this study

Who is it for?: Any age
Conditions the study is for: Astigmatism
What is being tested?: Precizon toric intraocular lens and Tecnis toric intraocular lens
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: No sites listed yet
Study dates: Apr 2016to Oct 2016
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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

Who cannot join

Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery

About this study

This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

Read the detailed description

In cataract surgery, after phacoemulsification, intraocular lens should be implanted for patient's better visual acuity. When patient has large amount of corneal astigmatism, toric intraocular lens are recommended to correct the preexisting astigmatism.

Conditions: Astigmatism
Being tested: Precizon toric intraocular lens, Tecnis toric intraocular lens
Medical subject headings: Astigmatism

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Precizon toric intraocular lensDevice
Phacoemulsification and implantation of Precizon toric intraocular lens
Tecnis toric intraocular lensDevice
Phacoemulsification and implantation of Tecnis toric intraocular lens

Study groups in NCT03085901
Study group	Role	What they receive
Precizon toric intraocular lens	Active comparator	Cataract surgery and implantation of Precizon toric intraocular lens Receives: Device: Precizon toric intraocular lens
Tecnis toric intraocular lens	Active comparator	Cataract surgery and implantation of Tecnis toric intraocular lens Receives: Device: Tecnis toric intraocular lens

What is being measured

The primary outcome is the main question the study is designed to answer.

Postoperative refractive astigmatism
Diopter
Measured: postoperative 3 months

Secondary outcomes (1)

Postoperative visual acuity
logMAR
Measured: postoperative 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2016Oct 2016

First posted21 Mar 2017
Study startApr 2016
Primary completionJul 2016
Study completionOct 2016

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 AstigmatismStudies of the same condition, open and under way.
More trials run by Samsung Medical CenterThe 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: Single blind
Who is masked: Participant
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03085901
Sponsor's protocol ID: 2016-04-147
Status last verified: Mar 2017
First submitted: 11 Mar 2017
Last updated: 21 Mar 2017
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.
PubMed 30413154

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

All Astigmatism trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Clinical Outcomes of Toric Intraocular Lens
ClinicalTrials.gov ID: NCT03085901
Acronym / sponsor ID: 2016-04-147
Conditions: Astigmatism
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Samsung Medical CenterUniversity, hospital or other
Study start: Apr 2016 (actual)
Primary completion: Jul 2016 (actual)
Study completion: Oct 2016 (actual)
First posted: 21 Mar 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.

This study is to compare the clinical outcome of Precizon toric intraocular lens(IOL) to that of Tecnis toric IOL.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
Precizon toric intraocular lens	Active comparator	Device: Precizon toric intraocular lensCataract surgery and implantation of Precizon toric intraocular lens
Tecnis toric intraocular lens	Active comparator	Device: Tecnis toric intraocular lensCataract surgery and implantation of Tecnis toric intraocular lens

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patient with cataract and regular corneal astigmatism(between 0.50 diopter and 2.50 diopter considering both anterior and posterior corneal surface)

Key exclusion criteria (1 listed)

Amblyopia, irregular astigmatism, corneal opacity, glaucoma, retinal disease, history of ocular inflammation, previous other intraocular surgery

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
Precizon toric intraocular lensPhacoemulsification and implantation of Precizon toric intraocular lens	Device	Precizon toric intraocular lens
Tecnis toric intraocular lensPhacoemulsification and implantation of Tecnis toric intraocular lens	Device	Tecnis toric intraocular lens

Primary outcome

Postoperative refractive astigmatism
Time frame: postoperative 3 months
Diopter

1 secondary outcome

Postoperative visual acuity
Time frame: postoperative 3 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 21 Mar 2017.
Derived from this study: PubMed 30413154Jung NY, Lim DH, Hwang SS, Hyun J, Chung TY. Comparison of clinical outcomes of toric intraocular lens, Precizon vs Tecnis: a single center randomized controlled trial. BMC Ophthalmol. 2018 Nov 9;18(1):292. doi: 10.1186/s12886-018-0955-3.
Individual participant dataSharing planned: No

Related trials for Astigmatism

Not yet recruiting
Clinical Performance and Outcomes After Toric Lens Transition
Astigmatism
Not yet recruiting
The EYERISING Study
Myopia, Astigmatism
Active, not recruiting
P1 Toric Vs. Max 1day
Eye, Astigmatism
Recruiting
Evaluation of Two Monthly Silicone Hydrogel Multifocal Toric in Soft Contact Lens Wearers
Astigmatism, Myopia
Recruiting
Clareon TruPlus Study
Aphakia, Astigmatism

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 Precizon toric intraocular lens and Tecnis toric intraocular lens in people with Astigmatism, run by Samsung Medical Center.

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 1 inclusion and 1 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 21 Mar 2017. 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?

Postoperative refractive astigmatism (time frame: postoperative 3 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 NCT03085901, 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 21 Mar 2017.