Evaluation Of The Tear Film And Ocular Surface Alterations In Patients With Type 2 Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Mean change in Impression Cytology score of both the groups.
研究概览
简要总结
This is a cross-sectional comparative study comparing tear film and ocular surface alterations between diabetics and non-diabetics. This study will be conducted in Guru Nanak Eye Centre. It will comprise of two groups with sample size of 20 per group. Primary outcome will be mean change in Impression Cytology score of both groups. Secondary outcome comprises of mean change in Ocular Surface Disease Index scare, TBUT, Schirmer’s score, Ocular surface Staining, tear film biomarker IL-6, Meiboscore, and correlation between ocular surface changes and the tear film biomarker. Also correlation of all ocular surface changes with duration and severity of diabetes.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Group 1: Patients diagnosed with Diabetes Mellitus (Type II) Group 2: Age and gender matched non-diabetics coming for routine checkup 2.18-50 years of age.
排除标准
- •1.Patients with pre-existing autoimmune disorder.
- •2.Patients with renal failure.
- •3.Patients with ocular allergy.
- •4.Patients on any topical medication that may affect tear film.
- •5.Any ocular/ophthalmic surgery or trauma, which could affect corneal sensitivity and/or tear distribution within 6 months prior to screening.
- •Current or previous use of contact lens anticipated during the study or use 3 months prior to screening.
结局指标
主要结局
Mean change in Impression Cytology score of both the groups.
时间窗: BASELINE
次要结局
- Mean change in QOL(OSDI) score, TBUT, Schirmer’s & OSS.(BASELINE)
- Mean change in tear film biomarker (IL 6 levels).(BASELINE)
- Correlation between ocular surface changes & the tear film biomarker.(BASELINE)
- Mean change in Meiboscore using non-contact infrared meibography.(BASELINE)
- Correlation of all ocular surface changes with duration & severity of diabetes (HbA1c levels).(BASELINE)
研究者
DR PARUL JAIN
GURU NANAK EYE CENTRE, MAULANA AZAD MEDICAL COLLEGE