跳至主要内容
临床试验/CTRI/2021/08/035502
CTRI/2021/08/035502尚未招募不适用

Comparison of clinical and inflammatory markers for dry eye disease following phacoemulsification and manual small incision cataract surgery

JIPMER1 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2021年8月15日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
JIPMER
入组人数
86
试验地点
1
主要终点
Among patients undergoing cataract surgery by manual small incision cataract surgery and phacoemulsification:

研究概览

简要总结

Dry eye disease(DED) is currently defined as a multifactorial disease of the ocular surface characterized by a loss of homeostasis of the tear film and accompanied by ocular symptoms in which tear film instability and hyperosmolarity, ocular surface inflammation and neurosensory abnormalities play etiological roles. The new DED definition puts more emphasis on the homeostasis of the tear film and diagnostic homeostasis marker tests. A recommended work up for DED includes screening with a questionnaire and homeostasis markers (non-invasive tear break-up time, osmolarity and staining) in which case DED is diagnosed if the patient has symptoms and one of the homeostasis markers is positive even without the full battery of recommended tests. Cataract surgery has been shown to be responsible for transiently inducing or exacerbating dry eye; studies have shown uncomplicated phacoemulsification can increase dry eye symptoms but generally the symptoms resolve after about 3 months. The signs associated with post-cataract dry eye include decrease in tear break up time, increase ocular surface staining and changes in tear volume. There have been a few studies from India demonstrating the pattern of dry eye after cataract surgery. MSICS is one of the most commonly performed cataract surgeries in our country and is gradually being adopted worldwide. This study will help us know the incidence of DED after MSICS and phacoemulsification and if there a difference depending on surgical technique used viz. MSICS versus phacoemulsification. By calculating the incidence and pattern of dry eye after cataract surgery, we could develop new therapeutic strategies to reduce and treat post-operative dry eye more effectively.

Hypothesis: Patients undergoing cataract surgery by MSICS have greater occurrence and extent of dry eye disease as compared to phacoemulsification.

研究设计

研究类型
Observational

入排标准

年龄范围
41.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Inclusion criteria: Patients with senile cataract above the age of 40 years undergoing cataract surgery by MSICS or phacoemulsification.

排除标准

  • Exclusion criteria: 1.Patients developing intra-operative or post- operative complications.
  • 2.Glaucoma patients undergoing cataract surgery on prior topical anti-glaucoma medications.
  • 3.Patients using any topical medications on a long-term basis for other ocular conditions like glaucoma, uveitis, etc.
  • 4.Patients with lid abnormalities (entropion, ectropion, trichiasis) or exposure changes due to thyroid eye disease or facial nerve palsy.

结局指标

主要结局

Among patients undergoing cataract surgery by manual small incision cataract surgery and phacoemulsification:

时间窗: pre-operatively and post-op day 1, 3 weeks and 2 months

i.To compare ocular symptom scores, Schirmer’s I values, TBUT values and corneal surface staining score pre-operatively and post-op day 1, 3 weeks and 2 months

时间窗: pre-operatively and post-op day 1, 3 weeks and 2 months

ii.To compare tear film inflammatory markers (IL-1β, IL-6) and meibomian gland changes pre-operatively and post-op day 1, 3 weeks and 2 months

时间窗: pre-operatively and post-op day 1, 3 weeks and 2 months

iii. To compare impression cytology score pre-op, 3 weeks and 2 months.

时间窗: pre-operatively and post-op day 1, 3 weeks and 2 months

次要结局

  • To study the effect of age, gender and occupation on Schirmer’s I values, TBUT values, corneal surface staining score, impression cytology score, tear film inflammatory markers (IL-1β, IL-6) and meibomian gland changes in these patients(pre-operatively and post-op day 1, 3 weeks and 2 months)

研究者

发起方
JIPMER
申办方类型
Research institution and hospital

研究点 (1)

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