Clinical trial NCT07001306: Long-term Effects of SCL-wearing on Corneal Neuromediators and Postoperative Rehabilitation After SMILE
Official title: A Prospective Clinical Study of Long-term Effects of SCL-wearing on Corneal Neuromediators and Postoperative Rehabilitation After SMILE
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contact Lens Complication
Small Incision Lenticule Extraction
Keywords: small incision lenticule extraction
neuromediators
visual quality
corneal nerve regeneration
soft contact lens
Lead sponsor: Tongji University
Sponsor class: OTHER
Collaborators: name: Shanghai 10th People's Hospital
First posted: 2025-06-03
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with myopia who underwent SMILE surgery at Shanghai Tenth People's Hospital in Shanghai, China, from June 2023 to the present.

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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

Exclusion Criteria:

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

Primary outcomes:
measure: Quality of Vision (QOV) scores
timeFrame: baseline, 1 month, 3months, 6months
measure: contrast sensitivity function
timeFrame: baseline, 1moth, 3 moths, 6 months
measure: Corneal subepithelial nerve fibers
timeFrame: baseline, 1moth, 3 moths, 6 months
measure: Corneal stromal lenticule Neuromediators
timeFrame: baseline
measure: OSDI Questionnaire
timeFrame: baseline, 1moth, 3 moths, 6 months
Secondary outcomes:
measure: Tear film stability
timeFrame: baseline, 1moth, 3 moths, 6 months
measure: Corneal Aberration
timeFrame: baseline, 1moth, 3 moths, 6 months
measure: Corneal Densitometry
timeFrame: baseline, 1moth, 3 moths, 6 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth People's Hospital
Study officials:
References: