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CTRI Number  CTRI/2025/02/081395 [Registered on: 27/02/2025] Trial Registered Prospectively
Last Modified On: 19/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Descriptive correlational 
Study Design  Other 
Public Title of Study   A study that looks at the number and types of eye problems that happen in patients who are on machines to help them breathe in intensive care units at certain hospitals in Udupi district. It also examines what factors might increase the chances of these eye issues occurring  
Scientific Title of Study   A descriptive correlative study on incidence, nature, and risk factors of ocular surface diseases among mechanically ventilated patients in intensive care units of selected tertiary care centres of Udupi district. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tshering Namgay 
Designation  2nd Year NPCC 
Affiliation  Manipal College of Nursing 
Address  2nd Year NPCC, Dept of Medical Surgical Nursing, Manipal College of Nursing
Manipal Academy of Higher Education
Udupi
KARNATAKA
576104
India 
Phone    
Fax    
Email  tsheringnamgay69@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Anil Raj A 
Designation  Assistant Professor 
Affiliation  Manipal College of Nursing, MAHE Manipal 
Address  Assistant Professor, Dept of Medical Surgical Nursing, Manipal College of Nursing Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  7411892986  
Fax    
Email  anil.raj@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Melita Sheilini 
Designation  Associate Professor 
Affiliation  Manipal College of Nursing  
Address  Associate Professor, Dept of Medical Surgical Nursing, Manipal College of Nursing Manipal Academy of Higher Education

Udupi
KARNATAKA
576104
India 
Phone  8095976561  
Fax    
Email  shyli.mel@manipal.edu  
 
Source of Monetary or Material Support  
Kasturba Hospital Udupi - Hebri Rd, Madhav Nagar, Manipal, Karnataka, India, 576104 
 
Primary Sponsor  
Name  Tshering Namgay 
Address  NPCC Dept of Medical Surgical Nursing Manipal College of Nursing Manipal Manipal Academy of Higher Education Madhava Nagar, Manipal, Karnataka India - 576104  
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 
Dr Sagar M S  Kasturba Hospital  Dept of Critical care Medicine ICU 1 and ICU 2 Kasturba Hospital Hebri Rd Madhav Nagar Manipal Udupi Karnataka India 576104
Udupi
KARNATAKA 		 8202922444

sagar.ms@manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital IEC 2  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H188||Other specified disorders of cornea, (2) ICD-10 Condition: H100||Mucopurulent conjunctivitis, (3) ICD-10 Condition: H022||Lagophthalmos, (4) ICD-10 Condition: H178||Other corneal scars and opacities,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nil  Nil 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Mechanically ventilated patients with age above 18 years

Mechanical ventilated patients exceeding 48 hrs

Mechanically ventilated patients willing to participate or family or attendant willing to
participate if patients unable give consent 
 
ExclusionCriteria 
Details  Patients/family unwilling to participate in the study
Patients has prior diagnosis of ocular surface disease or any ophthalmologic condition

Patients who has facial and eye injury 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
-To determine the incidence of ocular surface disease in mechanically ventilated patients.
-To explore the risk factors for OSD in mechanically ventilated patients.
-To enumerate the nature of each ocular surface disease (time of onset, grading, and severity.)
-To correlate OSD with risk factors, APACHE II, SOFA score, RASS score and ventilator setting, use
of sedatives, use of inotropes, prone ventilation, and use of neuromuscular blockers. 		 all the outcome will be assessed after 48 hrs of patients on mechanical ventilation till the patient gets weaned off the mechanical ventilation, where they will be assessed daily. 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="98"
Sample Size from India="98" 
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)   03/03/2025 
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="6"
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  

Despite the prevalence of Ocular Surface Disease (OSD) in mechanically ventilated patients in ICUs, it remains the most commonly overlooked condition. This oversight occurs because ICU staff primarily focus on managing acute and life-threatening situations (Grixti et al., 2012; Saritas et al., 2013). Surprisingly, no comprehensive study on OSD has been conducted, and no data or management protocols for ocular complications exist. Additionally, research on this subject within India is scant. Therefore, there is a pressing need for a study that examines the incidence, nature, and risk factors of OSD and explores the correlations between these risk factors and clinical variables. Research could significantly influence patient outcomes by highlighting the importance of managing ocular complications in critically ill patients.

The result of the will help to gather extensive information on ocular surface disease (OSD), a condition that impacts the outermost layer of the eye. The data collected will aid in setting a standard and creating institutional procedures for evaluating, preventing, and treating the disorder. By examining the incidence of OSD, we can acquire significant knowledge into the various types and characteristics of the disorder and effective treatment techniques and strive towards enhancing the overall ocular well-being of mechanically ventilated patients.



 
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