Contact Lens Complication, Small Incision Lenticule Extraction
Conditions
Keywords
small incision lenticule extraction, neuromediators, visual quality, corneal nerve regeneration, soft contact lens
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.
Interventions
None listed
Sponsors
Shanghai 10th People's Hospital
yuhao shao
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| OSDI Questionnaire | baseline, 1moth, 3 moths, 6 months | 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. |
| contrast sensitivity function | baseline, 1moth, 3 moths, 6 months | 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. |
| Corneal subepithelial nerve fibers | baseline, 1moth, 3 moths, 6 months | 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. |
| Corneal stromal lenticule Neuromediators | baseline | 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. |
| Quality of Vision (QOV) scores | baseline, 1 month, 3months, 6months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Corneal Aberration | baseline, 1moth, 3 moths, 6 months | Preoperative corneal aberration measurements were performed using a Scheimpflug tomography system (Pentacam; Oculus GmbH, Wetzlar, Germany). Images of the highest quality (designated as OK) were selected for analysis. The coefficients for a standardized diameter of 8 ?mm were examined, followed by an assessment of the clinical significance of total higher-order aberrations (HOA, mm), spherical aberration (Z4, 0, mm), horizontal coma (Z3, 1, mm), vertical coma (Z3, -1, mm), horizontal trefoil (Z3, 3, mm), and oblique trefoil (Z3, -3, mm) in relation to visual quality. |
| Corneal Densitometry | baseline, 1moth, 3 moths, 6 months | The Pentacam HR was used to collect data on corneal densitometry values, which were expressed in grayscale units (GSUs), playing a crucial role in quantifying corneal clarity by monitoring transient haze-like reactions. The cornea was divided into four annular zones (0-2 mm, 2-6 mm, 6-10 mm, and 10-12 mm), each exhibiting distinct corneal densitometry values. Based on the anatomical layers of the cornea at different depths, it consists of four layers: a superficial anterior layer of 120 μm, a posterior layer located within the innermost part of the cornea measuring 60 μm; central layers calculated by subtracting thickness of the anterior and posterior layers from the total layer thickness; and a total layer. Corneal densitometry values were measured in the 0-2 mm and 2-6 mm to correspond to the corneal optical zone diameter of SMILE. |
| Tear film stability | baseline, 1moth, 3 moths, 6 months | Including corneal fluorescein staining score and tear film break-up time examination. Corneal fluorescein staining score The corneal fluorescein staining was observed in different regions under a cobalt blue filter and scored. The cornea was divided into three regions: upper, middle and lower. Scores were given based on the fluorescein staining of the corneal epithelium in each region. No staining was scored as 0 points, 1 point for 1 to 30 staining points, 2 points for more than 30 staining points and no fusion of the staining points, and 3 points for the presence of corneal patellar staining fusion, filamentous substances and ulcers, etc. The total score is 9 points. Tear film break-up time Instruct the patients to look straight ahead, observe with a slit lamp and cobalt blue filter, and measure the time when dry spots first appear on the cornea after one involuntary blinking movement with a stopwatch. Each patient is measured three times, and the average of the three measurements i |
Countries
China
Outcome results
None listed