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

NCT ID: NCT06650306

Last Updated: 2024-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-18

Study Completion Date

2026-06-30

Brief Summary

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

Detailed Description

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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

Conditions

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Contact Lens Complication

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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SCLs >10 years

high myopia patients who wear SCL more than 10 years before Small Incision Lenticule Extraction

This study does not involve any interventions

Intervention Type 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

This study does not involve any interventions

Intervention Type OTHER

This study does not involve any interventions

NW

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

This study does not involve any interventions

Intervention Type OTHER

This study does not involve any interventions

Interventions

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This study does not involve any interventions

This study does not involve any interventions

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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yuhao shao

OTHER

Sponsor Role lead

Responsible Party

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yuhao shao

MD

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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min Li, Dr

Role: CONTACT

+86 18817367841

Yuhao Shao, MD

Role: CONTACT

Facility Contacts

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yuhao shao, MD

Role: primary

+86 18956775865

Other Identifiers

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SHSY-IEC-5.0/23K74/P01

Identifier Type: -

Identifier Source: org_study_id

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