A Comparison of the Accuracy of Toric Intraocular Lens Formulas

NCT ID: NCT04776603

Last Updated: 2021-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-01-31

Study Completion Date

2020-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Astigmatism

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Group 1

group 1 includes patients who axial length(AL)\<26mm

No interventions assigned to this group

Group 2

group 2 includes patients who axial length(AL)≥26mm

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

21 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Wenzhou Medical University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Yune Zhao

Vice president of Eye Hospital of Wenzhou Medical University

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Zhejiang, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 27255241 (View on PubMed)

Kane 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.

Reference Type RESULT
PMID: 32371252 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Toric-CPJ

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.