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临床试验/CTRI/2024/10/075397
CTRI/2024/10/075397尚未招募不适用

Exploring the sensitivity and specificity of various macular function tests in mature cataracts and comparison to B Scan Ultrasonography at a tertiary care eye hospital in India

G Anuradha1 个研究点 分布在 1 个国家目标入组 96 人开始时间: 2024年10月28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
96
试验地点
1
主要终点
Conventional macular function tests were altered when there was an evident posterior segment abnormality seen on B scan and post operative OCT

研究概览

简要总结

•        Age-related cataracts are the leading cause of disease-related visual impairment globally, accounting for 94 million adults aged ≥50 years who experienced low vision or blindness in 2020.

•         Although  cataract is easily treatable, a significant number of patients with a visually significant cataract (that is, a cataract with severe visual loss) remain undiagnosed in communities, especially in rural areas, due to the limited availability of, or accessibility to, cataract screening.

•        Prevalence of mature cataracts is 11.4% in India.

•        In our hospital incidence of mature cataracts is 12.54% (from March-May 2024)

•        The diagnosis and treatment outcome measurement in cases of mature cataracts  is challenging.

•        Macular function tests  are required for the evaluation of the macular function with opaque media in conditions including dense cataract and vitreous hemorrhage.

•        Conventional macular function tests were altered when there was an evident posterior segment abnormality seen on B Scan. So, in setup where B Scan ultrasonography is not available, the conventional macular function tests do help in cases of mature cataracts.

OCULAR EXAMINATION: (pre operative )

1.Visual acuity( PL, PR In all 4 quadrants )

2.Slit lamp evaluation

3.Non contact tonometry

4.Dilated fundus examination

5.Following macular function tests were performed in dark room: Colour vision

Maddox rod test 1 and 2

Two point discrimination test

Entoptic phenomenon

B Scan ultrasonography

Post operative parameters (day 1):

•        1.post operative visual acuity

•        2.Dilated fundus examination

•        3. OCT scan

Data is collected and sensitivity and specificity values of each macular function test is correlated with B Scan results and postoperative retina changes ,OCT scan and visual outcome.

研究设计

研究类型
Observational

入排标准

年龄范围
41.00 Year(s) 至 89.00 Year(s)(—)
性别
All

入选标准

  • VISION WITH HAND MOVEMENTS, PERCEPTION OF LIGHT, PROJECTION OF RAYS(GRADE 4+,GRADE 5)sponcs grading.

排除标准

  • Immature cataract Secondary cataracts(uveitic,post silicone oil) Traumatic mature cataract Eyes with sluggish pupil reaction or RAPD and No PL Bilateral mature cataract.

结局指标

主要结局

Conventional macular function tests were altered when there was an evident posterior segment abnormality seen on B scan and post operative OCT

时间窗: Preoperative and Postoperative day 1

次要结局

  • Sensitivity & Speficity of each macular function tests(Preoperatively & Post operative day 1)

研究者

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

G Anuradha

Sankara eye hospital

研究点 (1)

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