Scansys, Pentacam, Keratoconus, Subclinical KeratoconusNCT06152484
Evolution of a Novel Optical Coherence Tomography Based Index in Diagnosing Keratoconus
An observational study of Scansys, Pentacam, Keratoconus, Subclinical Keratoconus, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Comparison of corneal topography based on oct OCT principle (CASIA2) with Pentacam and Scheimpflug-based biomechanical devices (Corvis ST) in screening and diagnosing keratoconus; and evaluation of the consistency with Pentacam in measuring corneal parameters (such as curvature and thickness). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Scansys, Pentacam, Keratoconus, Subclinical Keratoconus
- What is being tested?
- Pentacam, Corvis ST and CASIA2
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Apr 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients premedicated for refractive surgery
Who may be able to join
- Best corrected visual acuity (BCVA) ≥ 20/20;
- No other eye diseases except myopia and astigmatism;
- The cornea was transparent, and there was no cloud or pannus;
Who cannot join
- The presence of ocular diseases other than myopia and keratoconus;
- Ocular trauma;
- Previous ocular surgery; 4 Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 6. Pregnant and lactating women;
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Tiajin Eye Hospital
Tianjin, Tianjin Municipality
About this study
Official title: A Study on Evaluating the Consistency of CASIA2, Pentacam, and Corvis ST Measurement Parameters and the Diagnostic Efficacy of Early Keratoconus
Comparison of corneal topography based on oct OCT principle (CASIA2) with Pentacam and Scheimpflug-based biomechanical devices (Corvis ST) in screening and diagnosing keratoconus; and evaluation of the consistency with Pentacam in measuring corneal parameters (such as curvature and thickness).
- Being tested
- Pentacam, Corvis ST and CASIA2
- Keywords
- Scansys, Pentacam, Keratoconus, subclinical keratoconus
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam, Corvis ST and CASIA2Other
morphological and biomechanical parameters of corneal were obtain by CASIA2, Pentacam and Corvis ST
| Study group | Role | What they receive |
|---|---|---|
| Normal control group | Not described Receives: Other: Pentacam, Corvis ST and CASIA2 | |
| Subclinical keratoconus | Not described Receives: Other: Pentacam, Corvis ST and CASIA2 | |
| Keratoconus | Not described Receives: Other: Pentacam, Corvis ST and CASIA2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening and diagnosis ability
Evaluate the sensitivity and specificity of parameters measured by CASIA2, Pentacam in diagnosing keratoconus using Receiver operating characteristic curves (ROC), and compare the Ectasia Screening Similarity（ESS）and D-value diagnostic efficacy using Area under the ROC curve (AUROC). Use the Delong test to compare the accuracy of various parameters in diagnosing early keratoconus.
Measured: one year
Secondary outcomes (1)
Measurement consistency
The independent sample T-test is used to compare inter- group differences in baseline data. Use independent sample T-test and One-way ANOVA to evaluate the consistency of the measurement results (anterior and posterior corneal curvature, corneal refractive index, CCT) obtained by CASIA2 and Pentacam.Finally, the ultimate outcome（such ad：K1 K2 KMax CCT） indicates that the P-value between the two devices is less than 0.05 and ICC-value is more than 0.75.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2023
- Study start1 Jul 2023
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scansys, Pentacam, Keratoconus, Subclinical KeratoconusStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Prof, Study chair, Tiajin Eye Hospita
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06152484
- Sponsor's protocol ID
- KY2023063
- Status last verified
- Nov 2023
- First submitted
- 30 Oct 2023
- Last updated
- 30 Nov 2023
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study on Evaluating the Consistency of CASIA2, Pentacam, and Corvis ST Measurement Parameters and the Diagnostic Efficacy of Early Keratoconus
- ClinicalTrials.gov ID
- NCT06152484
- Acronym / sponsor ID
- KY2023063
- Keywords
- Scansys, Pentacam, Keratoconus, subclinical keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Apr 2024 (estimated)
- First posted
- 30 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.
Comparison of corneal topography based on oct OCT principle (CASIA2) with Pentacam and Scheimpflug-based biomechanical devices (Corvis ST) in screening and diagnosing keratoconus; and evaluation of the consistency with Pentacam in measuring corneal parameters (such as curvature and thickness).
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control group | – | Other: Pentacam, Corvis ST and CASIA2 |
| Subclinical keratoconus | – | Other: Pentacam, Corvis ST and CASIA2 |
| Keratoconus | – | Other: Pentacam, Corvis ST and CASIA2 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients premedicated for refractive surgery
Key inclusion criteria (3 listed)
- Best corrected visual acuity (BCVA) ≥ 20/20;
- No other eye diseases except myopia and astigmatism;
- The cornea was transparent, and there was no cloud or pannus;
Key exclusion criteria (3 listed)
- The presence of ocular diseases other than myopia and keratoconus;
- Ocular trauma;
- Previous ocular surgery; 4 Patients were required to stop wearing soft contact lenses for at least 2 weeks and rigid contact lenses for at least 4 weeks before examination; 6. Pregnant and lactating women;
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 |
|---|---|---|
| Pentacam, Corvis ST and CASIA2morphological and biomechanical parameters of corneal were obtain by CASIA2, Pentacam and Corvis ST | Other | Keratoconus, Normal control group, Subclinical keratoconus |
Primary outcome
screening and diagnosis ability
Time frame: one year
Evaluate the sensitivity and specificity of parameters measured by CASIA2, Pentacam in diagnosing keratoconus using Receiver operating characteristic curves (ROC), and compare the Ectasia Screening Similarity（ESS）and D-value diagnostic efficacy using Area under the ROC curve (AUROC). Use the Delong test to compare the accuracy of various parameters in diagnosing early keratoconus.
1 secondary outcome
Measurement consistency
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2023.
- Individual participant dataSharing planned: Undecided
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.
Yan Wang, Prof study chair
Tiajin Eye Hospita
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 Scansys, Pentacam, Keratoconus, Subclinical Keratoconus, run by Tianjin Eye 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 3 inclusion and 3 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 30 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 Shuangcheng Li, Master (022-27313336-7539, lscdoc@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
screening and diagnosis ability (time frame: one year). 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 30 Nov 2023.