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

NCT07001306 | Completed

• 5 other identifiers: SCL on SMILE visual quality202240131YJXYS-B-009YNCR2C0042023SQ03
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

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).

Conditions

Contact Lens Complication; Small Incision Lenticule Extraction

Keywords

small incision lenticule extraction; neuromediators; visual quality; corneal nerve regeneration; soft contact lens

Outcome Measures

Primary Outcomes (5)

• Quality of Vision (QOV) scores

  It consists of 10 items related to visual symptoms, including glare, halo, radiating light, foggy vision, blurred vision, visual distortion, diplopia, visual fluctuation, difficulty in focusing and difficulty in depth perception. Each item consists of three dimensions: frequency, severity and degree of distress. Therefore, this questionnaire contains a total of 30 questions. The answers to the above three dimensions respectively include four options, namely frequency: never, occasionally, often, and frequently; Severity: None, mild, moderate, severe; Degree of distress: None, a little, some, very much. The corresponding scores for the four options are 0, 1, 2, and 3 respectively. The higher the score, the worse the visual quality

  baseline, 1 month, 3months, 6months

• contrast sensitivity function

  Under sufficient correction conditions, dark adaptation lasted for 10 minutes. Using the CSV-1000 contrast sensitivity tester at a distance of 3 meters, under the conditions of bright vision (85 cd/m ²), bright glare (135 lx), dark vision (3 cd/m ²), and dark glare (28 lx) respectively, Test the highest CS level that can be distinguished at 3, 6, 12 and 18 c/d spatial frequencies one by one. At each spatial frequency, the examinee needs to point out the bar grid sight in the upper and lower two circular sight targets and report the direction of the bar grid. After the result is correct, gradually reduce the bar grid contrast until the examinee can no longer recognize it. The inverse of the lowest recognizable contrast at this time is the contrast sensitivity. Record in logarithmic units according to the grade value conversion table.

  baseline, 1moth, 3 moths, 6 months

• Corneal subepithelial nerve fibers

  In this study, the ACCMetrics V.2 software developed by the University of Manchester in the UK for the HRT confocal microscope of Heidelberg Company was used to conduct automatic quantitative analysis and data recording on three nerve fiber images at different positions selected in a single shoot. The parameters analyzed include corneal nerve fiber density (CNFD sterand/mm 2) and corneal nerve fiber length( CNFL, mm/mm 2), corneal nerve fiber area (CNFA mm2/mm 2), corneal nerve fiber width (CNFW mm ), etc. Each inspection is carried out by the same inspector to reduce subjective errors.

  baseline, 1moth, 3 moths, 6 months

• 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

• OSDI Questionnaire

  The impact of dry eye on the subjective symptoms of patients was evaluated from three dimensions: ocular symptoms, visual function, and environmental stimuli. There were a total of 12 items. Each symptom was divided into 5 levels according to the degree and occurrence frequency: 0 was considered as none. 1 point occurs sometimes; 2 minutes occurs approximately half of the time; 3 points occur frequently; 4 points occur continuously. The final OSDI score = the total of all scores ×100/ (the total number of assessment questions ×4), with a total score ranging from 0 to 100.

  baseline, 1moth, 3 moths, 6 months

Secondary Outcomes (3)

• Tear film stability

  baseline, 1moth, 3 moths, 6 months

• Corneal Aberration

  baseline, 1moth, 3 moths, 6 months

• Corneal Densitometry

  baseline, 1moth, 3 moths, 6 months

Study Arms (3)

SCLs >10 years

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

SCLs ≤10 years

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

NW

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

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 myopia who underwent SMILE surgery at Shanghai Tenth People's Hospital in Shanghai, China, from June 2023 to the present.

You may qualify if:

• 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

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
• Shanghai 10th People's Hospital: collaborator

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, China

Location

Biospecimen

Retention: SAMPLES WITH DNA

All samples were collected from participants with 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.

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 22, 2025
• First Posted: June 3, 2025
• Study Start: June 1, 2023
• Primary Completion: June 30, 2024
• Study Completion: May 20, 2025
• Last Updated: July 20, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)