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

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

Study Overview

• Status: Recruiting
• Conditions: Contact Lens Complication
• Intervention / Treatment: Other: This study does not involve any interventions

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

• Study Type: Observational
• Enrollment (Estimated): 80

Contacts and Locations

• Study Contact: Name: min Li, Dr; Phone Number: +86 18817367841; Email: rgswan@163.com
• Study Contact Backup: Name: Yuhao Shao, MD

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Shanghai Tenth People's Hospital
      • Contact: yuhao shao, MD; Phone Number: +86 18956775865; Email: Shaoyh199*@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients with high myopia who underwent SMILE surgery at Shanghai Tenth People's Hospital in Shanghai, China, between October 2020 and October 2023.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
SCLs >10 years; high myopia patients who wear SCL more than 10 years before Small Incision Lenticule Extraction	Other: This study does not involve any interventions; This study does not involve any interventions
SCLs ≤10 years; high myopia patients who wear SCL for 10 years or less before Small Incision Lenticule Extraction	Other: This study does not involve any interventions; This study does not involve any interventions
NW; high myopia patients who have not worn SCLs before Small Incision Lenticule Extraction	Other: This study does not involve any interventions; This study does not involve any interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal stromal lenticule Neuromediators	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal Aberration	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.	baseline
Corneal Densitometry	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.	baseline

Collaborators and Investigators

• Sponsor: yuhao shao

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: October 16, 2024
• First Submitted That Met QC Criteria: October 18, 2024
• First Posted (Actual): October 21, 2024

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Soft contact lenses; Corneal Neuromediator; Corneal optical density; Corneal aberration
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: SHSY-IEC-5.0/23K74/P01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No