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

yuhao shao

Status: Completed

Conditions: Small Incision Lenticule Extraction; Contact Lens Complication

Study type: Observational

Funder types: Other

Identifiers

NCT07001306

202240131 (Other Grant/Funding Number)

SCL on SMILE visual quality

YNCR2C004 (Other Grant/Funding Number)

YJXYS-B-009 (Other Grant/Funding Number)

2023SQ03 (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

90 participants in 3 patient groups

SCLs >10 years

Description:

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

SCLs ≤10 years

Description:

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

NW

Description:

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