Ciliary Muscle ThicknessNCT06109636
Correlation Analysis Between Corneal Biomechanics and Anterior Segment
An observational study of Ciliary Muscle Thickness and Anterior Sclera Thickness, run by Tianjin Eye Hospital at 1 site in China.
Trial summary
Evaluation of the ciliary muscle thickness, area, and anterior chamber angle, as well as anterior sclera thickness in subjects, to investigate the relationship between these measurements and corneal biomechanics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Ciliary Muscle Thickness, Anterior Sclera Thickness, Corneal Biomechanics
- What is being tested?
- Pentacam, Corvis ST and Casia2
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 4 Mar 2023to 1 Oct 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
- 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
- Corneal disease;
- Ocular trauma;
- Previous ocular surgery;
- Any anterior segment diseases except cataract;
- 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: Correlation Analysis Between In-vivo Corneal Biomechanical Properties and Anterior Segment in Chinese Population
Evaluation of the ciliary muscle thickness, area, and anterior chamber angle, as well as anterior sclera thickness in subjects, to investigate the relationship between these measurements and corneal biomechanics. Clarify whether aqueous humor displacement, anterior sclera, and ciliary muscles influence the assessment of in vivo corneal biomechanics.
- Being tested
- Pentacam, Corvis ST and Casia2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pentacam, Corvis ST and Casia2Other
scleral and ciliary muscle thickness were obtained by Casia2, biomechanical parameters were obtained by Pentacam and Corvis ST
| Study group | Role | What they receive |
|---|---|---|
| Normal group | 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.
scleral and ciliary muscle thickness
The thickness of scleral and ciliary muscle(Casia2, quantitative data through the utilization of its integrated ruler system)
Measured: one year
biomechanical parameters
The biomechanical parameters(Corvis ST, exporting the quality-assured csv files to analysis)
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 posted31 Oct 2023
- Study start4 Mar 2023
- Primary completion1 Oct 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ciliary Muscle ThicknessStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 50 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
- NCT06109636
- Sponsor's protocol ID
- KY2023025
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 31 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 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Analysis Between In-vivo Corneal Biomechanical Properties and Anterior Segment in Chinese Population
- ClinicalTrials.gov ID
- NCT06109636
- Acronym / sponsor ID
- KY2023025
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Tianjin Eye HospitalUniversity, hospital or other
- Study start
- 4 Mar 2023 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 31 Oct 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.
Evaluation of the ciliary muscle thickness, area, and anterior chamber angle, as well as anterior sclera thickness in subjects, to investigate the relationship between these measurements and corneal biomechanics. Clarify whether aqueous humor displacement, anterior sclera, and ciliary muscles influence the assessment of in vivo corneal biomechanics.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Normal group | – | 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 (6 listed)
- Corneal disease;
- Ocular trauma;
- Previous ocular surgery;
- Any anterior segment diseases except cataract;
- 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;
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 Casia2scleral and ciliary muscle thickness were obtained by Casia2, biomechanical parameters were obtained by Pentacam and Corvis ST | Other | Normal group |
Primary outcome
scleral and ciliary muscle thickness
Time frame: one year
The thickness of scleral and ciliary muscle(Casia2, quantitative data through the utilization of its integrated ruler system)
biomechanical parameters
Time frame: one year
The biomechanical parameters(Corvis ST, exporting the quality-assured csv files to analysis)
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 31 Oct 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
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 Ciliary Muscle Thickness and Anterior Sclera Thickness, 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 6 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 31 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?
scleral and ciliary muscle thickness (time frame: one year). The study lists 2 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 31 Oct 2023.