FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/08/072770 [Registered on: 20/08/2024] Trial Registered Prospectively
Last Modified On: 17/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Evaluation of intaocular pressure and retinal blood flow in preeclampsia (hypertensive pregnancy with protein in urine or organ damage) 
Scientific Title of Study   Evaluation of intraocular pressure and optical coherence tomography angiography parameters in preeclampsia 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ayush Arya 
Designation  Post graduate resident 
Affiliation  Guru Nanak Eye Centre 
Address  Room no. 52, Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, New Delhi

Central
DELHI
110002
India 
Phone  8059198517  
Fax    
Email  ayush28101997@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kirti Singh 
Designation  Director professor 
Affiliation  Guru Nanak Eye Centre 
Address  Room no 52, Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, New Delhi

Central
DELHI
110002
India 
Phone  8059198517  
Fax    
Email  mail4kirti@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ayush Arya 
Designation  Post graduate resident 
Affiliation  Guru Nanak Eye Centre 
Address  Room no 52, Department of Ophthalmology, Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, New Delhi

Central
DELHI
110002
India 
Phone  8059198517  
Fax    
Email  ayush28101997@gmail.com  
 
Source of Monetary or Material Support  
Guru Nanak Eye Centre, Maharaja Ranjeet Singh Marg, New Delhi, India, 110002 
 
Primary Sponsor  
Name  Guru Nanak Eye Centre 
Address  Maharaja Ranjeet Singh Marg, New Delhi, 110002 
Type of Sponsor  Government medical college 
 
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 
Ayush Arya  Guru Nanak Eye Centre  Room no 52, Department of ophthalmology, Maharaja Ranjeet Singh Marg, New Delhi 110002
Central
DELHI 		 8059198517

ayush28101997@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee MAMC  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: Z349||Encounter for supervision of normal pregnancy, unspecified, (2) ICD-10 Condition: O149||Unspecified pre-eclampsia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  40.00 Year(s)
Gender  Female 
Details  Pregnant patients of age 18 to 40 years and period of gestation more that 20 weeks. 
 
ExclusionCriteria 
Details  Chronic hypertension.
Systemic comorbidities likediabetes or coronary artery disease.
Obstetric conditions other than preeclampsia like gestational diabetes on medical management, twin pregnancies.
History of any ocular surgeries.
Smoking. 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Intraocular pressure and OCT angiography parameters.  At baseline 
 
Secondary Outcome  
Outcome  TimePoints 
Central corneal thickness & mean ocular perfusion pressure  At baseline 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   02/09/2024 
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="0"
Months="4"
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 - YES
  1. What data in particular will be shared?
    Response - All of the individual participant data collected during the trial, after de-identiļ¬cation.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ayush28101997@gmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 01-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   The physiological state of pregnancy and its complications like preeclampsia and eclampsia affect the ocular milieu. However, there is no consensus on how preeclampsia and its sequel affect IOP. This has a bearing on understanding the ocular blood flow alterations in preeclampsia and managing glaucoma patients during their pregnancy.
OCT-Angiography (OCT-A) is a non-invasive imaging modality which employs en face reconstruction of OCT combined with motion contrast processing of red blood cells and provides quantifiable parameters for assessing the microcirculation of retina and choroid in various layers. Though both IOP and BP get affected in preeclampsia, there have been very few studies describing OCTA changes in these subjects.
Therefore this study aims to evaluate IOP and OCTA parameters in subjects of preeclampsia to evaluate the intraocular blood flow and management of glaucoma in such patients.
 
Close