CataractNCT06148857
Total Corneal Astigmatism Prevalence in Cataract Patients
An observational study of Cataract, run by Peking University Third Hospital at 1 site in China.
Trial summary
The purpose of this study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cataract
- What is being tested?
- IOLMaster 700
- How many people
- 11,000 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.
Who may be able to join
- Patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.
Who cannot join
- Incomplete biometric data .
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
About this study
Official title: Prevalence Data for Total Corneal Astigmatism in Cataract Surgery Candidates
The purpose of this study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates.
Read the detailed description
The purpose of this retrospective study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates. Preoperative biometric data of all the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital, from January 2019 to May 2023, were collected and analyzed. Data sets with incomplete biometric data were excluded.
- Conditions
- Cataract
- Being tested
- IOLMaster 700
- Keywords
- cataract, astigmatism, prevalence
- Medical subject headings
- Cataract, Astigmatism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IOLMaster 700Diagnostic test
Also called the Abulafia-Koch formula, the Barrett toric calculator
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: At Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2023
- Study startNov 2023 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 11,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hong Qi, Dr., Principal investigator, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06148857
- Sponsor's protocol ID
- BLB2
- Status last verified
- Nov 2023
- First submitted
- 20 Nov 2023
- Last updated
- 28 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence Data for Total Corneal Astigmatism in Cataract Surgery Candidates
- ClinicalTrials.gov ID
- NCT06148857
- Acronym / sponsor ID
- BLB2
- Conditions
- Cataract
- Keywords
- cataract, astigmatism, prevalence
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 11,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 Nov 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates.
Detailed description
The purpose of this retrospective study is to report the prevalence data for total corneal astigmatism (TCA) in cataract surgery candidates. Preoperative biometric data of all the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital, from January 2019 to May 2023, were collected and analyzed. Data sets with incomplete biometric data were excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All the patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.
Key inclusion criteria (1 listed)
- Patients who underwent cataract surgery in the Department of Ophthalmology, Peking University Third Hospital from January 2019 to May 2023.
Key exclusion criteria (1 listed)
- Incomplete biometric data .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IOLMaster 700Also: the Abulafia-Koch formula, the Barrett toric calculatorThe 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. | Diagnostic test | – |
Primary outcome
total keratometric astigmatism
Time frame: At Enrollment
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.
Abulafia-Koch formula total corneal astigmatism
Time frame: At Enrollment
The AK formula, described by Abulafia et al, is a regression formula that calculates an estimated TCA using K astigmatism.
Barrett toric calculator total corneal astigmatism
Time frame: At Enrollment
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hong Qi, Dr. principal investigator
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Peking University Third Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hong Qi, Dr. (+8613901066889 ext. 010, doctorgihong@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
total keratometric astigmatism (time frame: At Enrollment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.