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RecruitingNCT07928973Updated Nov 10, 2026

Clinical Application of a Novel Corneal Biomechanical Device in Refractive Surgery

An interventional study of Corneal steady-state biomechanical measurement device, Pentacam and Corvis ST and Pentacam and Corvis ST in Corneal Biomechanics and Refractive Surgery, sponsored by Tianjin Eye Hospital. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by Tianjin Eye Hospital · Not applicable, Interventional, and Treatment

Updated Nov 10, 2026Newly registeredGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Sex
All
01

Study summary

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.

02

Conditions studied

  • Corneal Biomechanics
  • Refractive Surgery
03

In context

Lead sponsor

Tianjin Eye Hospital is the lead sponsor of 53 studies on the registry; 18 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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;
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    Normal group

    Device: Pentacam and Corvis ST

  • Experimental
    Steady-State Corneal Biomechanical Measurement Group

    Device: Corneal steady-state biomechanical measurement device, Pentacam and Corvis ST

Interventions

  • DeviceCorneal steady-state biomechanical measurement device, Pentacam and Corvis ST

    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.

  • DevicePentacam and Corvis ST

    Morphological and biomechanical parameters were obtained by Pentacam and Corvis ST

06

What researchers measure

Primary outcomes

  1. Postoperative residual refractive error

    Time frame: One year

  2. Visual acuity

    Time frame: One year

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Study locations

1 of 1 sites recruiting
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Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Nov 10, 2026
Show all 1 update
  1. Nov 10, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07928973
Lead sponsor
Tianjin Eye Hospital
Responsible party
Sponsor
First posted
Nov 10, 2026
Start date
Nov 4, 2026
Primary completion
Nov 1, 2027 (estimated)
Completion
Oct 31, 2028 (estimated)
Last update
Nov 10, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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