NCT06148857

Brief Summary

The purpose of this study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
11,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

November 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2023

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

November 20, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 28, 2023

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2023

Completed
Last Updated

November 28, 2023

Status Verified

November 1, 2023

Enrollment Period

Same day

First QC Date

November 20, 2023

Last Update Submit

November 20, 2023

Conditions

Keywords

cataractastigmatismprevalence

Outcome Measures

Primary Outcomes (3)

  • total keratometric astigmatism

    Total keratometry is calculated based on the anterior and posterior corneal surface radius and CCT using the thick lens formula with the actual indices of refractions for air (1.000), cornea (1.376), and aqueous (1.336) by IOLMaster 700. Total keratometric astigmatism is taken as the TCA measured by IOLMaster 700.

    At Enrollment

  • Abulafia-Koch formula total corneal astigmatism

    The AK formula, described by Abulafia et al, is a regression formula that calculates an estimated TCA using K astigmatism.

    At Enrollment

  • Barrett toric calculator total corneal astigmatism

    The Barrett toric calculator uses an unpublished mathematical prediction method of TCA based on anterior corneal measurements. AL, ACD, LT, WTW, and K data by IOLMaster 700 were input into the Barrett toric calculator. The target refraction, incision surgically induced astigmatism (SIA), and incision location were all set as 0. The output net astigmatism was recorded as TCA predicted by the Barrett toric calculator.

    At Enrollment

Interventions

IOLMaster 700DIAGNOSTIC_TEST

The IOLMaster 700, one of the most commonly used optical biometers for IOL power calculation, measures the anterior corneal surface radius using a telecentric keratometry. Additionally, it employs swept-source optical coherence tomography (SS-OCT) technology to simultaneously measures the posterior cornea surface radius and central corneal thickness (CCT). The AK formula, described by Abulafia et al., is a regression formula that calculates an estimated TCA using K astigmatism. The Barrett toric calculator uses an unpublished mathematical prediction method of TCA based on anterior corneal measurements.

Also known as: the Abulafia-Koch formula, the Barrett toric calculator

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.

You may qualify if:

  • Patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.

You may not qualify if:

  • Incomplete biometric data .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University Third Hospital

Beijing, Beijing Municipality, 100191, China

Location

MeSH Terms

Conditions

CataractAstigmatism

Condition Hierarchy (Ancestors)

Lens DiseasesEye DiseasesRefractive Errors

Study Officials

  • Hong Qi, Dr.

    Peking University Third Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2023

First Posted

November 28, 2023

Study Start

November 1, 2023

Primary Completion

November 1, 2023

Study Completion

December 1, 2023

Last Updated

November 28, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations