CataractNCT06354296
Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy
An observational study of Cataract, run by He Eye Hospital.
Trial summary
The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cataract
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2024to 31 Aug 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with cataract after RK
Who may be able to join
- Had a previous history of RK surgery
- IOL-Master is available
- There were no intraoperative and postoperative complications
- Obvious refraction was performed 1 to 6 months after cataract surgery
Who cannot join
- The investigator decided that it was not suitable for this study
About this study
The Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) [Holladay 1 (D-K)] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula.
Read the detailed description
Myopia is the most common cause of distance vision impairment. The prevalence of myopia has increased dramatically in the past few decades, especially in China. Corneal refractive surgery is an effective method to correct adult myopia. Radial keratotomy (RK) is one of the corneal refractive surgeries developed in the 1980s. Thirty years ago, many myopic patients underwent RK. As patients age, more and more patients have cataracts requiring cataract extraction and intraocular lens (IOL) implantation. The selection of appropriate and accurate IOL is an important factor to improve patient satisfaction. Recent studies have compared the accuracy of the newly developed IOL formula in patients with previous RK cataract. However, as a country with myopia and myopia surgery, there is no similar study in China. In addition, most patients with cataract after RK had lost ocular data before RK surgery. For RK patients without previous ocular data, how to accurately calculate the IOL power is still a clinical challenge.
- Conditions
- Cataract
- Keywords
- cataract, RK surgery, formula
- Medical subject headings
- Cataract
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of the IOL formula
To compare the accuracy of four intraocular lens (IOL) calculation formulas in cataract patients after radial keratotomy (RK). They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start15 Apr 2024 (estimated)
- Primary completion15 Aug 2024 (estimated)
- Study completion31 Aug 2024 (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.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- He Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354296
- Sponsor's protocol ID
- CAF2024
- Status last verified
- Apr 2024
- First submitted
- 3 Apr 2024
- Last updated
- 9 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Accuracy of Different Intraocular Lens Power Calculation Formulas in Cataract Patients With Prior Radial Keratotomy
- ClinicalTrials.gov ID
- NCT06354296
- Acronym / sponsor ID
- CAF2024
- Conditions
- Cataract
- Keywords
- cataract, RK surgery, formula
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- He Eye HospitalUniversity, hospital or other
- Study start
- 15 Apr 2024 (estimated)
- Primary completion
- 15 Aug 2024 (estimated)
- Study completion
- 31 Aug 2024 (estimated)
- First posted
- 9 Apr 2024 (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 Web-based Barret True K formula with no history formula has been proven to be a good choice for cataract patients after RK in several studies. The American society of cataract and refractive surgeons provides several IOL formulas for cataract patients who have undergone previous corneal refractive surgery. In cases where only IOL-Master data are available, Holladay 1 (Double-K) [Holladay 1 (D-K)] can be used for IOL power calculation in cataract patients with a history of RK. The traditional Haigis formula has also been shown to be effective for cataract patients after RK. To compare the accuracy of four intraocular lens (IOL) power calculation formulas in cataract patients after RK. They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula.
Detailed description
Myopia is the most common cause of distance vision impairment. The prevalence of myopia has increased dramatically in the past few decades, especially in China. Corneal refractive surgery is an effective method to correct adult myopia. Radial keratotomy (RK) is one of the corneal refractive surgeries developed in the 1980s. Thirty years ago, many myopic patients underwent RK. As patients age, more and more patients have cataracts requiring cataract extraction and intraocular lens (IOL) implantation. The selection of appropriate and accurate IOL is an important factor to improve patient satisfaction. Recent studies have compared the accuracy of the newly developed IOL formula in patients with previous RK cataract. However, as a country with myopia and myopia surgery, there is no similar study in China. In addition, most patients with cataract after RK had lost ocular data before RK surgery. For RK patients without previous ocular data, how to accurately calculate the IOL power is still a clinical challenge.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with cataract after RK
Key inclusion criteria (4 listed)
- Had a previous history of RK surgery
- IOL-Master is available
- There were no intraoperative and postoperative complications
- Obvious refraction was performed 1 to 6 months after cataract surgery
Key exclusion criteria (1 listed)
- The investigator decided that it was not suitable for this study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Accuracy of the IOL formula
Time frame: Baseline
To compare the accuracy of four intraocular lens (IOL) calculation formulas in cataract patients after radial keratotomy (RK). They are Barrett True-K formula, Holladay 1(D-K) formula, Haigis formula, and MM formula
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by He Eye Hospital.
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 4 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 9 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the IOL formula (time frame: Baseline). 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 9 Apr 2024.