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临床试验/CTRI/2024/08/071883
CTRI/2024/08/071883尚未招募不适用

Temporal trends in visual acuity changes among individuals with gestational diabetes - a cohort study

Sana Kausar1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2024年8月8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
28
试验地点
1
主要终点
To measure Distance Visual acuity in LogMAR, Near Visual acuity in N notation and Refractive Error in Diopters.

研究概览

简要总结

IRC approval is obtained. Approvals from the Department of Gynaecology and Medical Superintendent KMC, Manipal. IEC approval will be obtained followed by CTRI registration before beginning of the study. After detailed explanation on the objective of the study and examination procedure, informed consent will be obtained from the participants before proceeding with the procedures. Participants between 18-45 years of the age will be recruited in this study. Initial screening will be done to confirm Inclusion and Exclusion criteria. Pregnant women diagnosed with Gestational Diabetes will be recruited for the study. Detailed history which includes family history, duration of Diabetes, medical history. Oral Glucose Tolerance test will be done to confirm the Gestational Diabetes. After relevant history, all the participants will undergo Distance Visual acuity assessment by using Log Mar Chart, near visual acuity assessment using a Near vision chart at 35-40 cm followed by Refraction in Both Eyes. Refraction will be done by Retinoscope and Huvitz HRK-1 Auto Ref Keratometer to measure the Refractive error in Diopters. After that, there is a follow up in the study in Second and third Trimester with one month gap. Two measurements will be taken in each Trimesters. After collecting the required data, the results will be compared with 1st , 2nd and 3rd Trimesters and analysis will be done to quantify the changes in visual parameters.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 45.00 Year(s)(—)
性别
Female

入选标准

  • 1.Gestational diabetes age between 18-45 years of age.
  • 2.Individual with Gestational Diabetes.
  • 3.With Oral glucose tolerance test positive will be included.
  • 4.Individuals using spectacle will be included.

排除标准

  • 1.Individuals having previously diagnosed ocular diseases like glaucoma, age-related macular degeneration, hypertensive retinopathy, optic nerve diseases or corneal diseases.
  • 2.Individuals having previously history of ocular surgery.
  • 3.Individual having Pre- Gestational Diabetes.

结局指标

主要结局

To measure Distance Visual acuity in LogMAR, Near Visual acuity in N notation and Refractive Error in Diopters.

时间窗: In second Trimester two times with one month gap

次要结局

  • To measure Distance Visual acuity, Near Visual acuity and Refractive Error(In third Trimester two times with one month gap)

研究者

发起方
Sana Kausar
申办方类型
Other [SELF ]
责任方
Principal Investigator
主要研究者

Sana Kausar

Manipal Academy Higher Education

研究点 (1)

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