NCT04776603

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2015

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 1, 2021

Completed
Last Updated

March 1, 2021

Status Verified

February 1, 2021

Enrollment Period

4.9 years

First QC Date

November 30, 2020

Last Update Submit

February 26, 2021

Conditions

Keywords

calculatorscataractintraocular lens powertoric

Outcome Measures

Primary Outcomes (1)

  • A Comparison of the Accuracy of Toric Intraocular Lens Formulas

    percentage of eyes with a prediction error within ±0.50 diopter (D)

    5 years

Study Arms (2)

Group 1

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

Group 2

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

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Zhejiang, China

Location

Related 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.

    PMID: 27255241BACKGROUND
  • 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.

MeSH Terms

Conditions

AstigmatismCataract

Condition Hierarchy (Ancestors)

Refractive ErrorsEye DiseasesLens Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Vice president of Eye Hospital of Wenzhou Medical University

Study Record Dates

First Submitted

November 30, 2020

First Posted

March 1, 2021

Study Start

January 1, 2015

Primary Completion

December 1, 2019

Study Completion

January 1, 2020

Last Updated

March 1, 2021

Record last verified: 2021-02

Locations