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临床试验/CTRI/2025/03/081530
CTRI/2025/03/081530尚未招募不适用

Assessment of Fundus Changes in Patients With Chronic Kidney Disease in a Tertiary Health Care Centre in Coimbatore

Mathan G1 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2025年3月10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
179
试验地点
1
主要终点
Assessment of morphological changes of fundus in CKD patients and the proportion of various fundus pathology is charted.

研究概览

简要总结

METHODOLOGY:

  1. CKD patients reported with ocular anomalies to the Department of

Ophthalmology / referred by the Department of General Medicine will

be undertaken as subject for the Prospective Observational Study

  1. Fundus examination for the patients will be carried out under eye

examination unit and instruments like slit lamp bio microscope,

Retinoscope (mirror and streak), Direct and indirect ophthalmoscope

will be used and adequate data will be collected

  1. Following appropriate protocol, assuring quality control, and assessing

through standard calibrated instruments, morphology findings will be

captured (colored and labelled pictures)and categorized. Data collected

will be recorded with the help of various statistical tools

  1. Through maintaining confidentiality and following ethical principles, the

data collected from the patient population will be analyzed and

categorized according to varying degree of fundus changes

  1. Fundus anomalies like DR, PDR, NPDR, Hypertensive retinopathy,

Mixed retinopathy, Venous occlusions, Age related Macular

Degeneration Drusen like deposits, Optic atrophy and retinal

detachment are categorized and segregated in groups. Incidence and

proportion of varying fundus changes in a tertiary health care centre is

reported

Prior studies indicated a high prevalence of ocular fundus pathology among patients with chronic kidney disease (CKD). The risk of development of retinopathy was significantly higher among older patients those with low haemoglobin level and high blood pressure. Retinopathy was significantly increased with reduction of e-GFR.

There was no direct significant relationship between BMI and serum lipid levels with retinal abnormality. The current study provides the morphological changes of fundus and the****proportion of varying degree of fundus changes in CKD patients in a tertiary health care centre, Coimbatore, Tamil Nadu. Thus it assist in improving the treatment protocols in terms of whether to treat or not treat/ whether to intensify or not to intensify therapy in order to minimise the major avoidable fundus complications in chronic kidney failure patients and this helps to narrow down ocular complications in advance.

研究设计

研究类型
Observational

入排标准

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

入选标准

  • Adult patients of chronic kidney disease of age above 18 of both sexes.

排除标准

  • Cases of reversible kidney injury -Renal transplant recipients -Patients on maintenance hemodialysis -Patient who refuses consent -Patient with any renal congenital anomaly.

结局指标

主要结局

Assessment of morphological changes of fundus in CKD patients and the proportion of various fundus pathology is charted.

时间窗: 12 months

次要结局

  • Better treatment methodology is suggested in advance and prevents the progression of disease(12 months)

研究者

发起方
Mathan G
申办方类型
Other [Investigator initiated]
责任方
Principal Investigator
主要研究者

Mathan G

KMCH Institute of Health Sciences and Research

研究点 (1)

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