A Comparison of the Accuracy of Toric Intraocular Lens Formulas

Completed

• Conditions: Astigmatism

• Registration Number: NCT04776603
• Lead Sponsor: Wenzhou Medical University

Brief 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

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 Timeline

• Study Start: 2015-01
• Primary Completion: 2019-12
• Study Completion: 2020-01
• Study First Submitted: 2020-11-30
• Status Verified: 2021-02
• Study First Submitted QC: 2021-02-26
• Last Update Submitted: 2021-02-26
• Study First Posted: 2021-03-01
• Last Update Posted: 2021-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
A Comparison of the Accuracy of Toric Intraocular Lens Formulas	5 years	percentage of eyes with a prediction error within ±0.50 diopter (D)