The Effect Of High And Low Molecular Weight Sodium Hyaluronic Acid Eye Drops On Corneal Recovery After Crosslinking
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Corneal nerve fiber density (CNFD)
研究概览
简要总结
Purpose: The objective of this investigation was to assess the impact of eye drops containing high molecular weight hyaluronic acid (HMW-HA) and low molecular weight hyaluronic acid (LMW-HA) on corneal nerve regeneration, dendritic cell (DC) density, corneal sensitivity (CS), and ocular surface parameters in patients with keratoconus following corneal crosslinking (CXL).
Methods: Sixty-three eyes of 55 keratoconus patients were randomized to instill eye drops containing HMW-HA (n: 20) for 12 months, LMW-HA (n:23) for 12 months and polyvinyl alcohol (n: 20) until the epithelial defect closure in the control group after CXL. Subbasal nerve plexsus (SNP) was imaged with corneal confocal microscopy (CCM) and ACCMetrics program was used to quantify corneal nerve fiber density (CNFD), corneal nerve fiber length (CNFL), corneal nerve fiber branching density (CNBD) and corneal nerve fiber total branching density (CTBD). DC density was calculated with Image J software. CS was measured using the Cochet-Bonnet esthesiometer. Ocular Surface Disease Index (OSDI) questionnaire, non-invasive break-up time (NI-TBUT) were evaluated. All measurements were performed before CXL and postoperatively after 1, 3, 6 and 12 months.
详细描述
This study assessed individuals aged 18 and above diagnosed with keratoconus and scheduled for epithelium-off CXL. A total of 63 eyes from 55 keratoconus patients were randomly assigned using computer-generated randomization (www.random.org/integers) into three groups: 20 eyes in the HMW-HA group, 23 eyes in the LMW-HA group, and 20 eyes in the control group without the administration of artificial tears.
Post-CXL, the HMW-HA group received topical HMW-HA (Comfort Shield®, i.com medical GmbH, Munich, Germany) three times daily for 12 months, the LMW-HA group received topical LMW-HA (Thealose Duo®, Thea, Clermont-Ferrand, France) three times daily for 12 months, and the control group received topical polyvinyl alcohol (Refresh, Allergan, Dublin, Ireland) three times daily until epithelial defect closure. All participants underwent accelerated epithelium-off CXL (A-CXL) for 10 minutes with 9 mW/cm² ultraviolet-A irradiation. The postoperative standard treatment regimen included topical moxifloxacin (0.5% Vigamox, Alcon Inc, USA) for one week, topical dexamethasone (0.1% Dexasine-SE, Kaysersberg Pharmaceuticals, France) for one week after epithelial closure, followed by topical loteprednol 0.5% (Lotemax, Bausch & Lomb, USA) for three weeks.
Uncorrected visual acuity (UCVA), best-corrected visual acuity (BCVA), and manifest spherical equivalent (SE) were recorded at all visits. The assessment was carried out in the following order: Ocular Surface Disease Index (OSDI) questionnaire, noninvasive tear break-up time (NIBUT), corneal tomography (Pentacam, OCULUS, Wetzlar, Germany), corneal sensitivity, corneal fluorescein staining, and CCM imaging. Examinations were conducted preoperatively and at the postoperative 1th, 3rd, 6th and 12th months.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Keratoconus patiens aged 18 and above who had been scheduled for corneal crosslinking
排除标准
- •Dry eye disease, corneal thickness below 400 micrometer, pregnancy, breastfeeding, topical or systemic drug use, eye disease other than keratoconus, systemic diseases, active atopy or allergy, contact lens use, ocular surgery history.
结局指标
主要结局
Corneal nerve fiber density (CNFD)
时间窗: Postoperative 1st, 3rd, 6th and 12th months
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFD.
Corneal nerve fiber total branching density (CTBD)
时间窗: Postoperative 1st, 3rd, 6th and 12th months
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CTBD.
Corneal nerve branch density (CNBD)
时间窗: Postoperative 1st, 3rd, 6th and 12th months
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNBD.
Corneal nerve fiber length (CNFL)
时间窗: Postoperative 1st, 3rd, 6th and 12th months
Automated tracing of nerve fibers program - CCMetrics (CCMetrics; M. A. Dabbah, ISBE, University of Manchester, Manchester, UK) was used to analyze CNFL
Corneal Sensitivity
时间窗: Postoperative 1st, 3rd, 6th and 12th months
Corneal sensitivity was assessed using a Cochet-Bonnet esthesiometer (Luneau Ophtalmologue, Chartes, France).
Ocular surface disease Index (OSDI) questionnaire
时间窗: Postoperative 1st, 3rd, 6th and 12th months
The Turkish validated version of the OSDI, a questionnaire assesing the clinical symptoms of the ocular surface disease, was used. The 4th and 5th questions in the first section, which inquire about blurred vision and reduced vision symptoms, were excluded from the questionnaire as they could already be present in patients with keratoconus disease.
Dendritic cell density
时间窗: Postoperative 1st, 3rd, 6th and 12th months
The Density of dendritic cells was calculated using ImageJ software (Image V.1.31; National Institutes of Health)
Non invaziv tear break-up time (NI-TBUT)
时间窗: Postoperative 1st, 3rd, 6th and 12th months
The tear break-up time (TBUT) was evaluated non-invasively using a Sirius Scheimpflug camera (CSO, Florence, Italy).
次要结局
- Visual Functions(Baseline)
- Refractive Outcomes(Postoperative 1st, 3rd and 6th months)
- Keratometric Findings(Postoperative 1st, 3rd and 6th months)