Clinical Application of a Novel Corneal Biomechanical Device in Refractive Surgery

November 4, 2026 updated by: Tianjin Eye Hospital

A Study of the Clinical Applications of a Novel Corneal Biomechanical Device in Refractive Surgery

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300020
        • Recruiting
        • Tianjin Eye Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Normal group
Device: Pentacam and Corvis ST

Morphological and biomechanical parameters were obtained by Pentacam and Corvis ST
Experimental: Steady-State Corneal Biomechanical Measurement Group
Device: Corneal 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Visual acuity
Time Frame: One year
One year
Postoperative residual refractive error
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Eye Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 4, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

November 4, 2026

First Submitted That Met QC Criteria

November 4, 2026

First Posted (Actual)

November 10, 2026

Study Record Updates

Last Update Posted (Actual)

November 10, 2026

Last Update Submitted That Met QC Criteria

November 4, 2026

Last Verified

November 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • KY-2026036

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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