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临床试验/CTRI/2026/01/100909
CTRI/2026/01/100909尚未招募不适用

Effectiveness of Topical 0.05 percent Cyclosporine in ocular surface disease among long term Antiglaucoma drugs users

All India Institute of Medical Sciences Gorakhpur1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2026年1月21日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
150
试验地点
1

研究概览

简要总结

This is a Hospital based Prospective Comparative study , in which 150 glaucoma patients on 2 or more topical antiglaucoma medication ( beta blocker + alpha 2 adrenergic agonist ) with or without prostaglandin analogue at least for 6 months will be recruited from OPD basis . Patients will be recruited after matching all inclusion and exclusion criteria and those who are willing to participate in study . Patients will be divided in 2 groups 1 group will be given topical cyclosporine 0.0.05 % along with topical antiglaucoma medication and other group will be given topical sodium hyaluronate 0.01% along with topical antiglaucoma medication.  Results will be compared in 8 outcome variables BCVA ( best corrected visual acuity), IOP ( intraocular pressure) , OSDI ( OCULAR SURFACE DISEASE INDEX), Schirmer test, TBUT ( Tear film break up time) , Conjunctival impression cytology by Nelson grading,  Corneal staining,  Tear film height . Outcome variables will be measured at time of recruitment for both cases and control and again at 8wk follow up. Then effectiveness of topical cyclosporine 0.05%  will be compared to topical sodium hyaluronate 0.01% after completion of follow up at 8 weeks .

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 80.00 Year(s)(—)
性别
All

入选标准

  • Patients having ocular surface disease after taking antiglaucoma drugs at least for 6 months.
  • 2 Patients taking combination therepy of topical antiglaucoma drugs (beta blocker+ alpha 2 adrenergic agonist) with or without prostaglandin analogue for at least 6 months.
  • Patients giving consent for study.

排除标准

  • Patients using contact lens.
  • Patients undergone punctal occlusion treatment or punctal cauterisation.
  • Patients undergone intraocular surgery and ocular laser treatment within last 6 months.
  • Patients allergic to cyclosporine.
  • 5.Patients using eye drops other than topical antiglaucoma drugs including artificial tear therepy.
  • Patients with pre existing ocular surface morbidities like recent ocular infection or inflammation, autoimmune disease, conjunctivitis, cicatricial conjunctivitis.

研究者

发起方
All India Institute of Medical Sciences Gorakhpur
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Dr Garima

ALL INDIA INSTITUTE OF MEDICAL SCIENCES GORAKHPUR UTTAR PRADESH INDIA

研究点 (1)

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