Ocular Surface and Corneal Morphological Changes After the Cataract Surgery and Associations With Inflammatory Biomarkers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears
研究概览
简要总结
This study is designed to explore dry eye disease (DED) pattern: ocular surface, corneal morphological changes, patients' subjective assessment of DED and their correlations with ocular surface inflammation, pain biomarkers after cataract surgery according to ocular surface lubrication with artificial tears during long-term follow-up.
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
- 50 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Cataract patients from 50 to 90 years old who underwent uncomplicated phacoemulsification performed by one (and same) experienced surgeon.
- •Patients with no underlying ocular surface diseases (keratitis, keratoconjunctivitis and others).
- •Patients who previously did not undergo any ophthalmic surgery.
排除标准
- •Patient expressed his wish to not participate in the study or discontinue it when already enrolled.
- •Severe dry eye disease diagnosed with OSDI/DEQ-5 and at least one of the following tests: TBUT less than 10 seconds, tear osmolarity higher than 308 mOsm/l or positive corneal staining.
- •Glaucoma.
- •Diabetes mellitus.
- •Systemic connective tissue disease, autoimmune disease.
- •Neurologic conditions including stroke, Bell's palsy, Parkinson's, trigeminal nerve dysfunction.
- •Patients who underwent refractive surgery (LASIK or PRK).
- •Contact lens users.
- •One or more of the following concomitant medications: psychiatric medicines, antihistamines and/or hormonal replacement.
- •Patients who are already regularly using topical drops or ointments.
结局指标
主要结局
Evaluation of matrix metalloproteinase-9 (MMP-9) levels in patients' tears
时间窗: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Matrix metalloproteinase 9 is an inflammatory biomarker that has been shown to be elevated in the tears of dry eye disease (DED) patients. MMP-9 testing is a valuable diagnostic tool in identifying the presence of ocular surface inflammation in DED patients. MMP-9 level results are classified as positive or negative.
Evaluation of tear cytokine levels
时间窗: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Interleukin -2, -6, -1β, tumour necrosis factor α (TNFα), interferon-gamma (IFN-γ) levels in tears are significantly higher in patients' with dry eye disease (DED) and they correlate with the severity of DED. Cytokine levels in tears will be evaluated using Human Immunotherapy Luminex® Performance Assay 25-plex Fixed Panel System.
Assessment of ocular surface changes following cataract surgery
时间窗: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Measured using LacryDiag (Quantel Medical, France), parameters included: non-invasive tear break up time, the height of the tear meniscus, interferometry.
Evaluation of the cornea morphology
时间窗: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluated performing confocal corneal microscopy, parameters include: corneal nerve fibre number and density.
Assessment of central corneal sensitivity
时间窗: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Measured using Cochet-Bonnet aesthesiometer (Luneau; Pruneay-Le-Gillon, France).
Evaluation of tear osmolarity
时间窗: 7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.
Evaluated with the TearLab Osmolarity System. Increased osmolarity indicates dry eye. Values greater than 300 mOsm/kg are suggestive of dry eye. From 300 mOsm/L to 320 mOsm/L, is graded as mild; from 320 mOsm/L to 340 mOsm/L, is graded as moderate; and greater than 340 mOsm/L, is graded as severe.
次要结局
- Dry Eye Questionnaire-5 (DEQ5) 5-item(7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.)
- Visual acuity evaluation (LogMAR)(7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.)
- Evaluation of potential pain biomarkers in patients' saliva(7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.)
- Ocular surface disease index (OSDI)(7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.)
- Visual function (VFQ-25) questionnaire(7 days preoperative, 1 week, 1, 3, 6,12 months postoperative.)
研究者
Reda Zemaitiene
Professor, Head of the Department of Ophthalmology at the Lithuanian University of Health Sciences
Lithuanian University of Health Sciences