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CTRI Number  CTRI/2024/08/071883 [Registered on: 05/08/2024] Trial Registered Prospectively
Last Modified On: 27/07/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   To check vision changes during diabetes that developed during pregnancy 
Scientific Title of Study   Temporal trends in visual acuity changes among individuals with gestational diabetes - a cohort study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sana Kausar 
Designation  2nd year Master of Optometry student 
Affiliation  Manipal Academy Higher Education 
Address  Department of Optometry Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi district Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9123196393  
Fax    
Email  sana1.mchpmpl2023@learner.manipal.edu  
 
Details of Contact Person
Scientific Query
 
Name  Ms Judith Shefali Jathanna 
Designation  Assistant Professor - Senior Scale 
Affiliation  Manipal Academy Higher Education 
Address  Department of Optometry Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi district Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9008754240  
Fax    
Email  judith.jathanna@manipal.edu  
 
Details of Contact Person
Public Query
 
Name  Sana Kausar 
Designation  2nd year Master of Optometry student 
Affiliation  Manipal Academy Higher Education 
Address  Department of Optometry Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi district Karnataka 576104 India

Udupi
KARNATAKA
576104
India 
Phone  9123196393  
Fax    
Email  sana1.mchpmpl2023@learner.manipal.edu  
 
Source of Monetary or Material Support  
Department of Optometry, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Sana Kausar 
Address  Department of Optometry Manipal College of Health Professions Manipal Academy of Higher Education Manipal Udupi district Karnataka 576104 India  
Type of Sponsor  Other [SELF ] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Sana Kausar  Kasturba Medical Hospital  Department Of Gynaecology and Obstetrics, Kasturba Medical Hospital, Manipal, Udupi district, Karnataka, 576104 India
Udupi
KARNATAKA 
9123196393

sana1.mchpmpl2023@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee - 2 (Student Research)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O244||Gestational diabetes mellitus,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  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. 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To measure Distance Visual acuity in LogMAR, Near Visual acuity in N notation and Refractive Error in Diopters.  In second Trimester two times with one month gap 
 
Secondary Outcome  
Outcome  TimePoints 
To measure Distance Visual acuity, Near Visual acuity and Refractive Error  In third Trimester two times with one month gap 
 
Target Sample Size   Total Sample Size="28"
Sample Size from India="28" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   08/08/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
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.
 
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