AstigmatismNCT04776603
A Comparison of the Accuracy of Toric Intraocular Lens Formulas
An observational study of Astigmatism, run by Wenzhou Medical University at 1 site in China.
Trial summary
To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Astigmatism
- How many people
- 172 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jan 2020
- 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 21 to 90 years
- All sexes
- Adult, Older adult
Study population: Patients who underwent cataract surgery at Eye hospital of Wenzhou Medical University,with insertion of the Alcon SN6AT(2-9) IOL(Alcon Laboratories, Inc, Fort Worth, TX)
Who may be able to join
- uncomplicated cataract surgery with a temporal clear corneal incision,with preoperative biometry using either the IOLMaster 500 (softwareversions 5.5 and 7.7) or 700 (software version 1.50; Carl Zeiss Meditec AG, Jena, Germany)
- subjective manifest refraction performed by any of the orthoptists in the practice and measurement of the actual postoperative axis of the IOL alignment performed in the same visit an average of 1 or 3months after surgery.
Who cannot join
- any corneal disease (keratoconus, other ectasia, pterygium, or previous trauma);
- previous ophthalmic operations, including laser vision correction, vitrectomy, pterygium surgery, penetrating glaucoma surgery, or scleral buckling procedures
- intraoperative or postoperative complications
- postoperative corrected distance visual acuity worse than 6/9
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparison of the Accuracy of Many Different Toric Intraocular Lens Formulas
To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes
Read the detailed description
To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes.Retrospective consecutive case series.One hundred seventy-two eyes of 172 patients who had a toric IOL inserted during surgery.One eligible eye from patients having uncomplicated cataract surgery with insertion of an Alcon SN6AT(2-9) IOL (Alcon Laboratories, Inc, Fort Worth, TX) from 1 surgeon were included in the study. pre-operative were measured using either the IOLMaster 500 or 700 (Carl Zeiss Meditec AG, Jena, Germany). Using vector calculation, the predicted postoperative refractive astigmatism was calculated for each formula. This was compared with the actual postoperative refractive astigmatism to give the prediction error.
- Conditions
- Astigmatism
- Keywords
- calculators, cataract, intraocular lens power, toric
- Medical subject headings
- Astigmatism, Cataract
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 |
|---|---|---|
| Group 1 | group 1 includes patients who axial length(AL)<26mm | |
| Group 2 | group 2 includes patients who axial length（AL）≥26mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
A Comparison of the Accuracy of Toric Intraocular Lens Formulas
percentage of eyes with a prediction error within ±0.50 diopter (D)
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2021
- Study startJan 2015
- Primary completionDec 2019
- Study completionJan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AstigmatismStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yune Zhao, Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04776603
- Sponsor's protocol ID
- Toric-CPJ
- Status last verified
- Feb 2021
- First submitted
- 30 Nov 2020
- Last updated
- 1 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Abulafia A, Koch DD, Wang L, Hill WE, Assia EI, Franchina M, Barrett GD. New regression formula for toric intraocular lens calculations. J Cataract Refract Surg. 2016 May;42(5):663-71. doi: 10.1016/j.jcrs.2016.02.038.
PubMed 27255241Kane JX, Connell B. A Comparison of the Accuracy of 6 Modern Toric Intraocular Lens Formulas. Ophthalmology. 2020 Nov;127(11):1472-1486. doi: 10.1016/j.ophtha.2020.04.039. Epub 2020 May 1.
PubMed 32371252
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Accuracy of Many Different Toric Intraocular Lens Formulas
- ClinicalTrials.gov ID
- NCT04776603
- Acronym / sponsor ID
- Toric-CPJ
- Conditions
- Astigmatism
- Keywords
- calculators, cataract, intraocular lens power, toric
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Jan 2015 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Jan 2020 (actual)
- First posted
- 1 Mar 2021 (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.
To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes
Detailed description
To compare the accuracy of the Abulafia-Koch, the Barrett, the Barrett Post ,the EVO , the new Holladay with total surgical-induced astigmatism, the Kane and and the Næser-Savini toric intraocular lens (IOL) power formulas using a large database of toric IOL refractive outcomes.Retrospective consecutive case series.One hundred seventy-two eyes of 172 patients who had a toric IOL inserted during surgery.One eligible eye from patients having uncomplicated cataract surgery with insertion of an Alcon SN6AT(2-9) IOL (Alcon Laboratories, Inc, Fort Worth, TX) from 1 surgeon were included in the study. pre-operative were measured using either the IOLMaster 500 or 700 (Carl Zeiss Meditec AG, Jena, Germany). Using vector calculation, the predicted postoperative refractive astigmatism was calculated for each formula. This was compared with the actual postoperative refractive astigmatism to give the prediction error.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | – | –group 1 includes patients who axial length(AL)<26mm |
| Group 2 | – | –group 2 includes patients who axial length（AL）≥26mm |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent cataract surgery at Eye hospital of Wenzhou Medical University,with insertion of the Alcon SN6AT(2-9) IOL(Alcon Laboratories, Inc, Fort Worth, TX)
Key inclusion criteria (2 listed)
- uncomplicated cataract surgery with a temporal clear corneal incision,with preoperative biometry using either the IOLMaster 500 (softwareversions 5.5 and 7.7) or 700 (software version 1.50; Carl Zeiss Meditec AG, Jena, Germany)
- subjective manifest refraction performed by any of the orthoptists in the practice and measurement of the actual postoperative axis of the IOL alignment performed in the same visit an average of 1 or 3months after surgery.
Key exclusion criteria (4 listed)
- any corneal disease (keratoconus, other ectasia, pterygium, or previous trauma);
- previous ophthalmic operations, including laser vision correction, vitrectomy, pterygium surgery, penetrating glaucoma surgery, or scleral buckling procedures
- intraoperative or postoperative complications
- postoperative corrected distance visual acuity worse than 6/9
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
A Comparison of the Accuracy of Toric Intraocular Lens Formulas
Time frame: 5 years
percentage of eyes with a prediction error within ±0.50 diopter (D)
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 1 Mar 2021.
- Background: PubMed 27255241Abulafia A, Koch DD, Wang L, Hill WE, Assia EI, Franchina M, Barrett GD. New regression formula for toric intraocular lens calculations. J Cataract Refract Surg. 2016 May;42(5):663-71. doi: 10.1016/j.jcrs.2016.02.038.
- Results publication: PubMed 32371252Kane JX, Connell B. A Comparison of the Accuracy of 6 Modern Toric Intraocular Lens Formulas. Ophthalmology. 2020 Nov;127(11):1472-1486. doi: 10.1016/j.ophtha.2020.04.039. Epub 2020 May 1.
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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 Astigmatism, run by Wenzhou Medical 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 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 1 Mar 2021. 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. 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?
A Comparison of the Accuracy of Toric Intraocular Lens Formulas (time frame: 5 years). 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 NCT04776603, which also lists 2 linked publications.
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 1 Mar 2021.