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临床试验/NCT07001306
NCT07001306已完成不适用

A Prospective Clinical Study of Long-term Effects of SCL-wearing on Corneal Neuromediators and Postoperative Rehabilitation After SMILE

yuhao shao1 个研究点 分布在 1 个国家目标入组 90 人开始时间: 2023年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
90
试验地点
1
主要终点
Quality of Vision (QOV) scores

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •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

排除标准

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

结局指标

主要结局

Quality of Vision (QOV) scores

时间窗: 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

contrast sensitivity function

时间窗: 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

时间窗: 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

时间窗: 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.

OSDI Questionnaire

时间窗: 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.

次要结局

  • 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)

研究者

发起方
yuhao shao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

yuhao shao

MD

Tongji University

研究点 (1)

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