FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/05/033843 [Registered on: 27/05/2021] Trial Registered Prospectively
Last Modified On: 26/05/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Eye findings in critically ill in a tertiary care hospital- A clinical study 
Scientific Title of Study   Ocular findings in critically ill patients in a tertiary care hospital- A clinical study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Anooj asif P A 
Designation  Ophthalmology Resident 
Affiliation  Yenepoya University  
Address  Yenepoya Medical College Deralakatte,Karnataka India
Yenepoya Medical College Deralakatte,Karnataka India
Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  anoojasif@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rashmi Jain 
Designation  Additional professor ,Ophthalmology 
Affiliation  Yenepoya Medical College 
Address  Yenepoya Medical College Department of Ophthalmology 5th Floor Deralakatte,Karnataka India

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  rashmijain@yenepoya.edu.in  
 
Details of Contact Person
Public Query  
Name  Dr Rashmi Jain 
Designation  Additional professor ,Ophthalmology 
Affiliation  Yenepoya Medical College 
Address  Yenepoya Medical College Department of Ophthalmology 5th Floor Deralakatte,Karnataka India

Dakshina Kannada
KARNATAKA
575018
India 
Phone    
Fax    
Email  rashmijain@yenepoya.edu.in  
 
Source of Monetary or Material Support  
YENEPOYA Medical College  
 
Primary Sponsor  
Name  YENEPOYA MEDICAL COLLEGE 
Address  DERALAKATTE ,MANGALORE,KARNATAKA,575018 
Type of Sponsor  Private 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 
Dr Anooj Asif  Yenepoya Medical College  Department of ophthalmology 5th floor DERALAKATTE
Dakshina Kannada
KARNATAKA 		 7759835569

anoojasif@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Yenepoya Ethics Committee 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  ALL AGE GROUPS FROM 19YEARS
ALL GCS SCORES FROM 3 TO 15 
 
ExclusionCriteria 
Details  Patients of pediatric age group (upto 18years).
Patients who refuse consent for examination. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
RELATIONSHIP BETWEEN ICU STAY AND OCULAR SYMPTOMS DETECTED  3months, 6months, 9months, 12months 
 
Secondary Outcome  
Outcome  TimePoints 
nil  nil 
 
Target Sample Size   Total Sample Size="188"
Sample Size from India="188" 
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)   01/06/2021 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NIL 
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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

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

  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 - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 21-12-2022 and end date provided 21-12-2027?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  
Patients in the intensive care unit (ICU), present physicians with new challenges in diagnosis and management on a daily basis.  ICU patients may present with multiple organ involvement with a wide range of signs and symptoms that guides the practitioner  in making a correct diagnosis. Ophthalmologic symptoms are as important for making an appropriate diagnosis as a patient’s cough, nausea, or edema.

 Neglecting examination of the eye in the course of attempting to make a correct diagnosis would  would not only disregards valuable information about the patient thereby the physician may overlook an important aspect in the overall treatment of the patient.

 Advancements in ICU care have inadvertently led to increase in the length of ICU stay which in turn resulted an increase in complications directly related to duration of stay.previous studies regarding the same have revealed that the patients under critical care are more susceptible to certain ocular conditions.

 Patients are more susceptible in the intensive care unit as they have dysfunctional ocular protective mechanisms due to metabolic derangement , mechanical ventilation and decreased level consciousness. Sedated ICU patients are incapable of protecting their eyes.Hence, patients are more susceptible to Ocular surface disorders.

 

 Ocular Diseases whose prevalence has been proven to be more in critically ill are

 

Exposure keratitis

Chemosis

Angle Closure Glaucoma

Diabetic retinopathy

Central retinal artery occlusion

Central retinal vein occlusion

Rhino Orbital Cerebral Mucormycosis

Endophthalmitis

MRSA related ophthalmological infections.

 
Close