A Comparison of the Accuracy of Toric Intraocular Lens Formulas

Sponsor

Wenzhou Medical University (Other)

Overall Status

Completed

CT.gov ID

NCT04776603

Collaborator

(none)

172

Enrollment

Location

Actual Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Condition or Disease	Intervention/Treatment	Phase
Astigmatism

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

Study Type:

Observational

Actual Enrollment :

172 participants

Observational Model:

Case-Only

Time Perspective:

Retrospective

Official Title:

A Comparison of the Accuracy of Many Different Toric Intraocular Lens Formulas

Actual Study Start Date :

Jan 1, 2015

Actual Primary Completion Date :

Dec 1, 2019

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Group 1 group 1 includes patients who axial length(AL)<26mm
Group 2 group 2 includes patients who axial length（AL）≥26mm

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 90 Years

Sexes Eligible for Study:

All

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