Keratoconus, StableNCT05748002
Evaluation of Morphology Abnormal Cornea Stability With Corneal Biomechanical
An observational study of Keratoconus, Stable, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Keratoconus, Stable
- What is being tested?
- Pentacam and Corvis ST
- How many people
- 315 participants
- Where
- 1 siteChina
- Study dates
- 16 Jul 2018to 1 Dec 2022
- 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;
- No clinical manifestation of keratoconus（Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring） Exclusion Criteria:1) corneal disease;
- 2) ocular trauma; 3) 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; 4) Pregnant and lactating women;
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index
To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.
- Conditions
- Keratoconus, Stable
- Being tested
- Pentacam and Corvis ST
- Medical subject headings
- Keratoconus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam and Corvis STOther
morphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST
| Study group | Role | What they receive |
|---|---|---|
| stable group | Not described Receives: Other: Pentacam and Corvis ST | |
| subclinical keratoconus | Not described Receives: Other: Pentacam and Corvis ST | |
| normal group | Not described Receives: Other: Pentacam and Corvis ST | |
| follow up group | Not described Receives: Other: Pentacam and Corvis ST |
What is being measured
The primary outcome is the main question the study is designed to answer.
stable
No alterations in morphological(Pentacam parameters, BAD<0.42, TCT<10μm) and biomechanical(Corvis ST, parametersCBI<0.2, SPA1<10) parameters between the first and last follow-up.
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 posted28 Feb 2023
- Study start16 Jul 2018
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Keratoconus, StableStudies 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
- Prospective
- Enrolment
- 315 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
- NCT05748002
- Sponsor's protocol ID
- 2023002
- Status last verified
- Oct 2023
- First submitted
- 17 Feb 2023
- Last updated
- 23 Oct 2023
- 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 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction for Abnormal Topography Corneas Using New Biomechanical Parameter - Biomechanical Stable Index
- ClinicalTrials.gov ID
- NCT05748002
- Acronym / sponsor ID
- 2023002
- Conditions
- Keratoconus, Stable
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 315 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 28 Feb 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.
To evaluate the corneal biomechanical properties of stable eyes with abnormal morphology, and introduce a biomechanical stable index to evaluate the stability of the eyes with abnormal morphology at the first diagnosis.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| stable group | – | Other: Pentacam and Corvis ST |
| subclinical keratoconus | – | Other: Pentacam and Corvis ST |
| normal group | – | Other: Pentacam and Corvis ST |
| follow up group | – | Other: Pentacam and Corvis ST |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients premedicated for refractive surgery
Key inclusion criteria (5 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;
- No clinical manifestation of keratoconus（Corneal stromal thinning, Cone-shaped anterior protrusions, Fleischers ring, Vogts striae, Epithelial or subepithelial scarring） Exclusion Criteria:1) corneal disease;
- 2) ocular trauma; 3) 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; 4) Pregnant and lactating women;
Key exclusion criteria (0 listed)
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 and Corvis STmorphological and biomechanical parameters of corneal were obtain by Pentacam and Corvis ST | Other | follow up group, normal group, stable group, subclinical keratoconus |
Primary outcome
stable
Time frame: one year
No alterations in morphological(Pentacam parameters, BAD<0.42, TCT<10μm) and biomechanical(Corvis ST, parametersCBI<0.2, SPA1<10) parameters between the first and last follow-up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Keratoconus, Stable
Enrolling by invitationObservational study
Corneal Biomechanical Analysis Using Brillouin Microscopy
Keratoconus, Keratoconus, Unstable
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 Keratoconus, Stable, 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 5 inclusion and 0 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: finished, as of the sponsor's last update on 23 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
stable (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 23 Oct 2023.