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

NCT06650306 — Completed, 80 participants, yuhao shao

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RegistryNCT06650306
StatusCompleted
Study typeObservational
Enrollment80 (Actual)
Sponsoryuhao shao (Other)
ConditionsContact Lens Complication
InterventionsThis study does not involve any interventions (Other)
Datesstart 2024-10-18, primary completion 2026-06-30, completion 2026-06-30, first posted 2024-10-21, last updated 2026-10-20
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Contact Lens Complication All trials of This study does not involve any interventions

-Summary

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

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+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

+Arms and interventions

ArmTypeInterventionsDescription
SCLs >10 yearsOther: This study does not involve any interventionshigh myopia patients who wear SCL more than 10 years before Small Incision Lenticule Extraction
SCLs ≤10 yearsOther: This study does not involve any interventionshigh myopia patients who wear SCL for 10 years or less before Small Incision Lenticule Extraction
NWOther: This study does not involve any interventionshigh myopia patients who have not worn SCLs before Small Incision Lenticule Extraction
  • This study does not involve any interventions (Other): This study does not involve any interventions

+Outcome measures

Primary outcomes

  • Corneal stromal lenticule Neuromediators [baseline]: Corneal neuromediators, including NGF(pg/mL), CGRP(pg/mL), SP(pg/mL), IGFBP-1(ng/mL), and MANF(pg/mL), which play pivotal roles in maintaining normal physiological functions of the cornea.

Secondary outcomes

  • Corneal Aberration [baseline]: Preoperative corneal aberration measurements were performed using a Scheimpflug tomography system (Pentacam; Oculus GmbH, Wetzlar, Germany). Images of the highest quality (designated as OK) were selected for analysis. The coefficients for a standardized diameter of 8 ?mm were examined, followed by an assessment of the clinical significance of total higher-order aberrations (HOA, mm), spherical aberration (Z4, 0, mm), horizontal coma (Z3, 1, mm), vertical coma (Z3, -1, mm), horizontal trefoil (Z3, 3, mm), and oblique trefoil (Z3, -3, mm) in relation to visual quality.
  • Corneal Densitometry [baseline]: The Pentacam HR was used to collect data on corneal densitometry values, which were expressed in grayscale units (GSUs), playing a crucial role in quantifying corneal clarity by monitoring transient haze-like reactions. The cornea was divided into four annular zones (0-2 mm, 2-6 mm, 6-10 mm, and 10-12 mm), each exhibiting distinct corneal densitometry values. Based on the anatomical layers of the cornea at different depths, it consists of four layers: a superficial anterior layer of 120 μm, a posterior layer located within the innermost part of the cornea measuring 60 μm; central layers calculated by subtracting thickness of the anterior and posterior layers from the total layer thickness; and a total layer. Corneal densitometry values were measured in the 0-2 mm and 2-6 mm to correspond to the corneal optical zone diameter of SMILE.

+Eligibility

Sex: All, ages: 18 Years to 45 Years, accepts healthy volunteers

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.

+Locations (1)

FacilityCityCountryStatus
Shanghai Tenth People's HospitalShanghai, Shanghai MunicipalityChina