| 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
|
|
|
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
|
|
|
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. |