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NCT Number: NCT06650306

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

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Location status: Recruiting

Location contact

yuhao shao, MD

CONTACT

Shaoyh199*@163.com

+86 18956775865

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

This study does not involve any interventions

Other

This study does not involve any interventions

Primary outcomes

  1. Corneal stromal lenticule Neuromediators

    Time frame: 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

  1. Corneal Aberration

    Time frame: 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.

  2. Corneal Densitometry

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yuhao Shao, MD

CONTACT

min Li, Dr

CONTACT

[email protected]

+86 18817367841

Sponsors and collaborators

Lead sponsor

yuhao shao

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Oct 21, 2024
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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