Clinical Application of a Novel Corneal Biomechanical Device in Refractive Surgery
Corneal Biomechanics · Refractive Surgery
What this study involves
The registry says this study is recruiting. Individual locations may have different availability.
- Study type
- Interventional
- Phase
- Not applicable
- Age range
- Not specified - Not specified
- Sex eligible
- All sexes
- Healthy volunteers
- Accepted
- Participants
- 200 Estimated
These are starting points, not an eligibility decision. The research team must review the full requirements.
About the research
This study aims to evaluate the accuracy of corneal Young's modulus measurements (E\_CID and E\_Steady-State) obtained using a steady-state corneal biomechanical measurement device in patients scheduled to undergo refractive surgery and to explore their potential applications in assisting refractive surgical procedures.
Who may be able to participate?
The list below is the sponsor’s full registry wording. It can include conditions, prior treatment, test results and other requirements. A match in search does not mean you qualify.
Inclusion Criteria:
1. Best corrected visual acuity (BCVA) ≥ 20/20;
2. No other eye diseases except myopia and astigmatism;
3. The cornea was transparent, and there was no cloud or pannus;
Exclusion Criteria:
1. Corneal disease;
2. Ocular trauma;
3. Previous ocular surgery;
4. Any anterior segment diseases except cataract;
5. 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;
Treatment, groups and participation
The registry may describe treatments and study duration without a complete visit calendar. Ask the study team for the exact schedule, procedures, risks, costs and alternatives. Keep your usual care plan unless your treating clinician tells you otherwise.
- Assignment
- Random assignment
- Masking
- Triple masked
Normal group
Not reported in this registry record.
Device: Pentacam and Corvis ST
Steady-State Corneal Biomechanical Measurement Group
Not reported in this registry record.
Device: Corneal steady-state biomechanical measurement device, Pentacam and Corvis ST
Corneal steady-state biomechanical measurement device, Pentacam and Corvis ST DEVICE
Participants wear negative-pressure goggles, and a pressure test is performed to ensure an adequate seal. They then position their chin on the chinrest and fixate on a target while the operator aligns the imaging system with the cornea. The device applies controlled negative pressure and captures corneal deformation images using a Scheimpflug camera, with a coaxial imaging system assisting in alignment and monitoring eye movements. Following data acquisition, the software analyzes corneal biomechanical parameters and generates an assessment report.
Pentacam and Corvis ST DEVICE
Morphological and biomechanical parameters were obtained by Pentacam and Corvis ST
What researchers are measuring
Outcome measures describe what is being studied. They are not proof that a treatment works.
Primary measures
Postoperative residual refractive error
Time frame: One year
Not reported in this registry record.
Visual acuity
Time frame: One year
Not reported in this registry record.
Review the complete result tables and limitations in the official record.
Open official results ↗Research locations (1)
The overall study status and a local site’s status can differ. Confirm that location’s availability before traveling.
1 locations
Tianjin Eye HospitalTianjin, Tianjin Municipality, ChinaRecruiting
Study team and timeline
- Lead sponsor
- Tianjin Eye Hospital
- Study start
- Nov 4, 2026 Actual
- Primary completion
- Nov 1, 2027 Estimated
- Study completion
- Oct 31, 2028 Estimated
- First posted
- Nov 10, 2026 Actual
- Last updated
- Nov 10, 2026 Actual
Official study contacts
No central contact is listed. Check the locations and the official record.
Official study title
A Study of the Clinical Applications of a Novel Corneal Biomechanical Device in Refractive Surgery
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Source: ClinicalTrials.gov API v2. Information is submitted by sponsors and investigators. NLM does not approve the safety or science of all listed studies. Registry disclaimer.
Retrieved: Nov 12, 2026 · Last registry update: Nov 10, 2026