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

NCT06650306 | Recruiting

• 1 other identifier: SHSY-IEC-5.0/23K74/P01
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Contact Lens Complication

Keywords

Corneal Neuromediator; Soft contact lenses; Corneal optical density; Corneal aberration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Corneal Aberration

  baseline

• Corneal Densitometry

  baseline

Study Arms (3)

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

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

NW

high myopia patients who have not worn SCLs before Small Incision Lenticule Extraction

Other: This study does not involve any interventions

Interventions

This study does not involve any interventions OTHER

This study does not involve any interventions

NW; SCLs >10 years; SCLs ≤10 years

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• yuhao shao: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

All samples were collected from participants with high myopia who underwent SMILE surgery. The VisuMax femtosecond laser system (Carl Zeiss Meditec, Jena, Germany) was utilized with the following settings: a repetition rate of 500 kHz, pulse energy of 150 nJ, intended cap thickness of 110-120 μm, and optical zone of 6.0-6.8 mm. A circumferential incision width of 2 mm was made for lenticule dissection and extraction. The surgical procedures were performed by a single experienced surgeon (Dr. Zou). Following the SMILE surgeries, corneal stromal lenticules were transferred to Eppendorf tubes and stored at -80°C. for subsequent analysis.

Central Study Contacts

min Li, Dr

CONTACT

+86 18817367841; rgswan@163.com

Yuhao Shao, MD

CONTACT

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: October 16, 2024
• First Posted: October 21, 2024
• Study Start: October 18, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: October 21, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)