A Comparison of the Accuracy of Toric Intraocular Lens Formulas

Astigmatism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04776603
• Other study ID #: Toric-CPJ
• Status: Completed
• Start date: January 2015
• Est. completion date: January 2020

Study information

• Verified date: February 2021
• Source: Wenzhou Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: January 2020
• Est. primary completion date: December 2019
• Gender: All
• Age group: 21 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Astigmatism

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Wenzhou Medical University

Country where clinical trial is conducted

China, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	A Comparison of the Accuracy of Toric Intraocular Lens Formulas	percentage of eyes with a prediction error within ±0.50 diopter (D)	5 years