ScansysNCT06119321
A Study of a Novel Scheimpflug Device in Diagnosing Keratoconus
An observational study of Scansys and Pentacam, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Comparison of the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- Pentacam, Corvis ST and Scansys
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 4 May 2023to 31 Dec 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;
- 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;
- Pregnant and lactating women;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus
Comparison of the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus.
- Conditions
- Scansys, Pentacam, Corvis ST, Keratoconus, Subclinical Keratoconus
- Being tested
- Pentacam, Corvis ST and Scansys
- 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 ScansysOther
morphological and biomechanical parameters of corneal were obtain by Scansys, Pentacam and Corvis ST
| Study group | Role | What they receive |
|---|---|---|
| Normal control group | Not described Receives: Other: Pentacam, Corvis ST and Scansys | |
| Subclinical keratoconus | Not described Receives: Other: Pentacam, Corvis ST and Scansys | |
| Keratoconus | Not described Receives: Other: Pentacam, Corvis ST and Scansys |
What is being measured
The primary outcome is the main question the study is designed to answer.
screening and diagnosis ability
Calculate the cut-off values, sensitivity and specificity of parameters measured by Pentacam, Corvis ST and Scansys in diagnosing keratoconus. Use Receiver operating characteristic curves (ROC) to analyze the optimal parameters to distinguish between the three groups.
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 posted7 Nov 2023
- Study start4 May 2023
- Primary completion1 Nov 2023
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ScansysStudies 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 (actual)
Sponsor and investigators
- Lead sponsor
- Tianjin Eye Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yan Wang, Prof, Study chair, Tianjin Eye Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119321
- Sponsor's protocol ID
- KY2023026
- Status last verified
- Oct 2024
- First submitted
- 25 Oct 2023
- Last updated
- 4 Nov 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Novel Scheimpflug Device for Detection of Early Keratoconus
- ClinicalTrials.gov ID
- NCT06119321
- Acronym / sponsor ID
- KY2023026
- Conditions
- Scansys, Pentacam, Corvis ST, Keratoconus, Subclinical Keratoconus
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 4 May 2023 (actual)
- Primary completion
- 1 Nov 2023 (actual)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 7 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 the screening and diagnosis ability of the novel Scheimpflug-based tomography device (Scansys) with Pentacam and the Scheimpflug-based biomechanics device (Corvis ST) for keratoconus.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal control group | – | Other: Pentacam, Corvis ST and Scansys |
| Subclinical keratoconus | – | Other: Pentacam, Corvis ST and Scansys |
| Keratoconus | – | Other: Pentacam, Corvis ST and Scansys |
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 (5 listed)
- The presence of ocular diseases other than myopia and keratoconus;
- Ocular trauma;
- Previous ocular surgery;
- 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;
- 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 Scansysmorphological and biomechanical parameters of corneal were obtain by Scansys, Pentacam and Corvis ST | Other | Keratoconus, Normal control group, Subclinical keratoconus |
Primary outcome
screening and diagnosis ability
Time frame: one year
Calculate the cut-off values, sensitivity and specificity of parameters measured by Pentacam, Corvis ST and Scansys in diagnosing keratoconus. Use Receiver operating characteristic curves (ROC) to analyze the optimal parameters to distinguish between the three groups.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2024.
- 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
Tianjin Eye 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 Scansys and Pentacam, 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 5 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 4 Nov 2024. 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?
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?
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 4 Nov 2024.