Menu
Recruiting NCT06650306

The Impact of Soft Contact Lenses on the Corneal Neuromediators and Optical Quality in High Myopia Prior to SMILE

Observational Contact Lens Complication

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: This study does not involve any interventions.
Who it may be relevant to
Registry conditions: Contact Lens Complication. Basic parameters: 18 years — 45 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

To investigate the influence of Neuromediators expression in corneal stromal lenticules and corneal injury repair after small incision extraction

Detailed description

This study included 160 eyes from high myopia patients who underwent Small Incision Lenticule Extraction. Patients were devided into three groups based on duration of wearing SCLs: \> 10 years group, ≤ 10 years group, and NW group (not SCLs). Corneal higher-order aberrations and densitometry were evaluated using a Pentacam system. Neuromediator levels in corneal stromal lenticules were analyzed using ELISA and immunofluorescence

Interventions

  • Other This study does not involve any interventions
    This study does not involve any interventions

Primary outcome measures

  • Corneal stromal lenticule Neuromediators [Time frame: baseline]
Secondary outcome measures (2)
  • Corneal Aberration [Time frame: baseline]
  • Corneal Densitometry [Time frame: baseline]

Eligibility criteria

Inclusion criteria

  • age ≥ 18 years with stable refraction for at least two years;
  • spherical equivalent (SE) < -6.00 D;
  • corrected distance visual acuity of 20/20 or better;
  • no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination

Exclusion criteria

\- a history of moderate to severe dry eye as well as any ocular or systemic disease that would contraindicate laser refractive surgery.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

China · 1 center
  • Shanghai Tenth People's Hospital — Shanghai

Identifiers

NCT: NCT06650306 · SHSY-IEC-5.0/23K74/P01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗