CataractNCT01978106
Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator
An observational study of Cataract and Astigmatism, run by Yonsei University at 1 site in South Korea.
Trial summary
Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. Read more about this study
- Who is it for?
- Ages 33 to 87 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract, Astigmatism
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2013to Apr 2013
- Phase
- Observational
- 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 33 to 87 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects who planned to undergo cataract removal by phacoemulsification between January 2013 to April 2013 at the Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea were included in this study.
Who may be able to join
- Subjects who planned to undergo cataract removal by phacoemulsification
- Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry
Who cannot join
- Subjects with more than 2.74 D of corneal keratometric value from autokeratometry
- a history of intraocular or corneal surgery and ocular trauma
- biomicroscopic evidence of corneal disease that could affect corneal astigmatisms
- contact lens wearer
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Institute of Vision Research, Department of Ophthalmology, Yonsei University College of Medicine
Seoul, 120-752
About this study
Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.
- Conditions
- Cataract, Astigmatism
- Keywords
- toric calculator, toric intraocular lens power, Acrysof, Tecnis, iTrace
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| a WTR corneal astigmatism group | Corneal astigmatism was defined as WTR when the steep corneal cylinder axis was within 30 degrees of the horizontal axis. | |
| an ATR corneal astigmatism group | Corneal astigmatism was defined as ATR when the cylinder axis was within 30 degrees of the vertical axis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference of toric intraocular lens power between three toric calculators
Comparison of the toric intraocular lens power calculated from Acrysof and TECNIS toric calculators using keratometric values measured by autokeratometry or IOLMaster PCI and that from iTrace toric calculator with keratometric value measurement using iTrace ray tracing wavefront aberrometry and iTrace simulated keratometry.
Measured: Immediately after measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2013 (estimated)
- Study startJan 2013
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Yonsei 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yonsei University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01978106
- Sponsor's protocol ID
- 1-2013-0041
- Status last verified
- Nov 2013
- First submitted
- 31 Oct 2013
- Last updated
- 7 Nov 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparisons of the Astigmatic Power of Toric Intraocular Lens Using Three Toric Calculators: AcrySof, TECNIS, and iTrace Toric Calculator
- ClinicalTrials.gov ID
- NCT01978106
- Acronym / sponsor ID
- 1-2013-0041
- Conditions
- Cataract, Astigmatism
- Keywords
- toric calculator, toric intraocular lens power, Acrysof, Tecnis, iTrace
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yonsei UniversityUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 7 Nov 2013 (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.
Purpose of this study is to compare the astigmatic power of the toric IOL obtained from the AcrySof toric calculator, TECNIS toric calculator, and iTrace toric calculator in a group of patients with preoperative with-the-rule (WTR) and against-the-rule (ATR) corneal astigmatism. The study included 100 eyes with cataract and greater than 0.75 diopter of corneal astigmatism, and the subjects were divided into WTR and ATR group. Keratometric value was measured using autokeratometry, IOLMaster partial coherence interferometry (PCI), iTrace incorporating corneal topography and ray-tracing aberrometry. Based on measured values, toric IOL power calculations were performed using AcrySof, TECNIS and iTrace toric calculators.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| a WTR corneal astigmatism group | – | –Corneal astigmatism was defined as WTR when the steep corneal cylinder axis was within 30 degrees of the horizontal axis. |
| an ATR corneal astigmatism group | – | –Corneal astigmatism was defined as ATR when the cylinder axis was within 30 degrees of the vertical axis. |
Who may qualify
- Ages
- 33 to 87 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects who planned to undergo cataract removal by phacoemulsification between January 2013 to April 2013 at the Department of Ophthalmology, Yonsei University College of Medicine, Seoul, South Korea were included in this study.
Key inclusion criteria (2 listed)
- Subjects who planned to undergo cataract removal by phacoemulsification
- Subjects with preoperative corneal astigmatism greater than 0.75 D, as determined by autokeratometry
Key exclusion criteria (4 listed)
- Subjects with more than 2.74 D of corneal keratometric value from autokeratometry
- a history of intraocular or corneal surgery and ocular trauma
- biomicroscopic evidence of corneal disease that could affect corneal astigmatisms
- contact lens wearer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference of toric intraocular lens power between three toric calculators
Time frame: Immediately after measurement
Comparison of the toric intraocular lens power calculated from Acrysof and TECNIS toric calculators using keratometric values measured by autokeratometry or IOLMaster PCI and that from iTrace toric calculator with keratometric value measurement using iTrace ray tracing wavefront aberrometry and iTrace simulated keratometry.
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 7 Nov 2013.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract and Astigmatism, run by Yonsei University 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 2 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 7 Nov 2013. 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?
Difference of toric intraocular lens power between three toric calculators (time frame: Immediately after measurement). 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 7 Nov 2013.