Long-term Effects of SCL-wearing on Corneal Neuromediators and Postoperative Rehabilitation After SMILE

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

COMPLETED

Total Enrollment

90 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-06-01

Study Completion Date

2025-05-20

Brief Summary

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To investigate the effects of neuromediators in corneal stromal lenticules from patients with long-term soft contact lens (SCL) wear on corneal nerve regeneration and visual quality recovery following small incision lenticule extraction (SMILE).

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Detailed Description

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he prospective cohort study recruited 90 patients who underwent SMILE between June 2023 and June 2024. 90 eyes were categorized into three groups according to the duration of wearing SCL: the \> 10 years group (25 eyes), the ≤ 10 years group (35 eyes), and the non-wear (NW) group (30 eyes). Pre- and post-operative assessments at 1, 3 and 6 months included corneal higher-order aberrations (HOAs), corneal optical density, tear film breakup time (BUT), corneal fluorescein staining, subepithelial corneal nerve fiber parameters, Ocular Surface Disease Index (OSDI), Quality of Vision (QOV) scores, and contrast sensitivity function (CSF). nerve growth factor (NGF), insulin-like growth factor binding protein-1 (IGFBP-1), mesencephalic astrocyte-derived neurotrophic factor (MANF), calcitonin gene-related peptide (CGRP) and substance P (SP) in stromal lenticules were quantified using ELISA. Multiple linear regression analysis was employed to evaluate the associations between SCL wear duration, mediator levels, and postoperative outcomes.

Conditions

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Contact Lens Complication Small Incision Lenticule Extraction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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SCLs >10 years

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

No interventions assigned to this group

SCLs ≤10 years

myopia patients who wear SCL for 10 years or less before Small Incision Lenticule Extraction

No interventions assigned to this group

NW

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

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* age ≥ 18 years with stable refraction for at least two years;
* corrected distance visual acuity of 20/20 or better;
* no history of using rigid gas permeable lenses or orthokeratology (OK) lenses prior to examination