Clinical trial NCT04776603: A Comparison of the Accuracy of Toric Intraocular Lens Formulas
Official title: A Comparison of the Accuracy of Many Different Toric Intraocular Lens Formulas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Astigmatism
Keywords: calculators
cataract
intraocular lens power
toric
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2021-03-01
Enrollment: 172
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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)

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.

Eligibility criteria: 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

Primary outcomes:
measure: A Comparison of the Accuracy of Toric Intraocular Lens Formulas
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Zhejiang
country: China
Study officials:
References:
citation: 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.
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.