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临床试验/CTRI/2024/10/076023
CTRI/2024/10/076023尚未招募2 期

The effect of 0.5 percentage Carboxymethylcellulose on corneal thickness in glaucoma and non glaucoma patients a stratified randomised control trial

Namitha N Rose1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2025年11月6日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
120
试验地点
1
主要终点
• To compare the effect of carboxy methylcellulose (0.5%) in glaucoma patients and non-glaucoma patients in terms of

研究概览

简要总结

Glaucoma is a leading cause of blindness prevailing in the world. In the United States, glaucoma is the second leading cause of blindness and it is the most frequent cause of blindness among African -Americans.. It was estimated that 12 million Indians would have  been affected by 2020. Epidemiological studies on glaucoma involving adults age 40 years and above have estimated glaucoma prevalence between 2.7 and 4.3% among indians. The goal of treatment of glaucoma is to lower the rate of progression throughout a patient’s lifetime in order to maintain visual function and related quality of life. Elevation of Intraocular pressure remains as a treatable risk factor and is known to be associated with the progression of glaucoma

A long-term therapy with topical intraocular pressure lowering agents is usually necessary to preserve the visual field and thus patients’ quality of life. Most of the patients with glaucoma require long term or lifelong use of eye drops which is associated with ocular surface diseases and thinning of cornea. Topical antiglaucoma medications depending on the class, could cause thinning, thickening or no change to the CCT.

Ocular Lubricants when used is found to cause an increase in the central corneal thickness often after 2 weeks to one month of therapy in dry eye from the base line. This study is designed to investigate the effect of lubricants (0.5% carboxymethylcellulose -CMC- which is used as artificial tears in opd regularly and harmless with no side effects reposted as of now) on the central and peripheral corneal thickness and epithelial thickness in the glaucoma patients and non-glaucoma subjects.it is found to be beneficial it will  become a boon the glaucoma patients with corneal thinning.

  • There are very few studies that have actually studied the CCT and mid PCT of glaucoma and non-glaucoma patients. Here we determine the CCT and mid PCT of glaucoma and non-glaucoma patients with and without carboxy methylcellulose. We determine the changes in the 3 zones of CET and CCT -namely central zone (0-2mm), paracentral zone (2-5 mm) and mid peripheral zone (5-7mm).
  • None of studies have got any relevant information about a ratio between central epithelial to central corneal thickness. In this study, we try to assess if there is any difference in CET to CCT ratio among glaucoma and non-glaucoma patients with and without lubricants.
  • If we can prove by the study that there is an increase in CCT and mid PCT with the use of lubricants in glaucoma patients, instilling lubricants along with antiglaucoma medications will improve the corneal thickness from the baseline and thus patients’ quality of life.

Hence the study becomes significant.

研究设计

研究类型
Interventional
分配方式
Coin toss, Lottery, toss of dice, shuffling cards etc
盲法
Participant Blinded

入排标准

年龄范围
30.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Cases 1.Glaucoma patients using one or more of the same topical antiglaucoma medications for at least 3 months.
  • Controls 1.Non glaucoma subjects who are matched for age (± 5) and gender of the glaucoma patients.

排除标准

  • 1.PATIENTS WITH ANY OTHER OCULAR OR CLINICALLY RELEVANT SYSTEMIC DISEASES (MEIBOMIAN GLAND DYSFUNCTION, SJOGREN SYNDROME, STEVEN JOHNSON SYNDROME).
  • 2.HISTORY OF LUBRICANT INSTILLATION IN PAST 2 MONTHS 3.TREATMENT WITH ANY OTHER OPHTHALMIC DRUG EXCEPT TOPICAL ANTIGLAUCOMA DRUGS 4 WEEKS PRECEDING STUDY.
  • 4.HISTORY OF OCULAR SURGERY IN PAST 6 MONTHS.
  • KNOWN HYPERSENSITIVITY TO CARBOXYMETHYLCELLULOSE.

结局指标

主要结局

• To compare the effect of carboxy methylcellulose (0.5%) in glaucoma patients and non-glaucoma patients in terms of

时间窗: 1 MONTH

• central corneal thickness (CCT),

时间窗: 1 MONTH

• mid peripheral corneal thickness (PCT)

时间窗: 1 MONTH

• corneal epithelial thickness (CET)

时间窗: 1 MONTH

• central epithelial thickness to central corneal thickness ratio

时间窗: 1 MONTH

USING AS-OCT

时间窗: 1 MONTH

次要结局

  • • To estimate the corneal thickness in glaucoma and non-glaucoma controls without lubricants.(1 MONTH)

研究者

发起方
Namitha N Rose
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Namitha N Rose

Believers Church Medical College

研究点 (1)

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