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CTRI Number  CTRI/2024/04/065802 [Registered on: 16/04/2024] Trial Registered Prospectively
Last Modified On: 23/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Follow Up Study 
Study Design  Other 
Public Title of Study   study of factors such as diabetes, energy used during surgery ,medications used after that which affect dry eye symptoms post cataract surgery (a.k.a phacoemulsification) 
Scientific Title of Study   Study of the factors affecting dry eye following phacoemulsification  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Neetha KIR 
Designation  Associate proffesor 
Affiliation  Kasturba medical college ,Manipal 
Address  Unit 001 ,Room no 25 Dept of Ophthalmology , Kasturba Hospital , Manipal ,Udupi ,

Udupi
KARNATAKA
576104
India 
Phone  9999880065  
Fax    
Email  neetha.kir@manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Neetha KIR 
Designation  Associate proffesor 
Affiliation  Kasturba medical college ,Manipal 
Address  Unit 001 ,Room no 25 Dept of Ophthalmology , KH. Manipal Udupi ,Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9886161979  
Fax    
Email  neetha.kir@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Vriti Suneja  
Designation  Junior resident 
Affiliation  Kasturba medical college ,Manipal 
Address  Room no 25 Dept of Ophthalmology , Kasturba Hospital , Manipal Udupi ,Karnataka 576104

Udupi
KARNATAKA
576104
India 
Phone  9999880065  
Fax    
Email  vriti.suneja16@gmail.com  
 
Source of Monetary or Material Support  
Post graduate grant ,Kasturba Medical College ,MAHE Manipal Udupi, Karnataka 576104 
 
Primary Sponsor  
Name  Dept of OphthalmologyKasturba Hospital Kasturba Medical college Manipal 
Address  Dept. of Ophthalmology, Kasturba Hospital , Kasturba Medical college ,Manipal , Udupi,Karnataka 576104 
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 Vriti Suneja  Kasturba Hospital  Room no 25 , Dept of Ophthalmology , , Manipal
Udupi
KARNATAKA 		 9999880065

vriti.suneja16@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Comittee -2 (Student Research)  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 
Intervention  nil  nil 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Anyone fit for cataract surgery and is undergoing surgery at KH, manipal .who is willing and consented to be part of the study.
 
 
ExclusionCriteria 
Details  Patients with lid disorders such as untreated meibomian gland disease; blepharitis;lag ophthalmos; bells palsy; and connective tissue disorders already been diagnosed with dry eye disease.
Any complication during the surgery or any modification to the surgery.
If the patient is on any topical medication including lubricants.
Any ocular condition such as uveitis, glaucoma or corneal diseases.
History of trauma to the eye
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Outcome measures include post-operative changes in OSDI scoring, ST-I, TBUT , LG staining and the correlation of the dry eye signs and symptoms with age, chronic disease presence, medications; site of the corneal incision; duration of exposure to microscopic light; C.D.E. value; type of lubricating eye drops used or not used.
 		 patient will be evaluated at pre-operative visit ,post surgery follow up at 2 weeks and at 6 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
Outcome measures include post-operative changes in OSDI scoring, ST-I, TBUT , LG staining and the correlation of the dry eye signs and symptoms with age, chronic disease presence, medications; site of the corneal incision; duration of exposure to microscopic light; C.D.E. value; type of lubricating eye drops used or not used.  3 month post surgery if patient is willing for follow up 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
Final Enrollment numbers achieved (Total)= "80"
Final Enrollment numbers achieved (India)="80" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/05/2024 
Date of Study Completion (India) 31/10/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="10"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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  

  1. aim and objectives: To determine association of post phacoemulsification dry eye with various risk factors such as :

  1. Baseline factors: age, gender, chronic illness, and medication they would be currently on.

  2. Intraoperative factors: microscopic light exposure time, C.D.E., incision site of the main incision: temporal, supra temporal or infratemporal, type of anaesthesia used: sub tenon, peribulbar or topical.

  3. Post-operatively: the different types of lubricating drops such as sodium hyaluronate, carboxymethyl cellulose eye drops, hydroxy propyl methyl-cellulose eye drops, or no eye drops at all.

           2 . Methodology
In this study the following tests will be used to assess the dry eye symptoms at pre-op visit; at 2 weeks  and 1 and half month follow up post surgery .3 month follow up would be done for patient who are compliant for the follow up.

  1. Schirmer’s test: type 1(ST-1)(to evaluate reflex and basal tear secretion}: The Schirmer test typically consists of a 35 * 5 mm strip of Whatman No. 41 filter paper that can be folded 5 mm from one end and is anchored to the patient’s lower eyelid. After 5 min, the amount of tear production is measured in millimeters; type 2:(to test basal tear secretion ) After Schirmer type 1, we instill anesthetic drops such as proparacaine eye drops and repeat the method of Schirmer’s type 1 measuring the amount of tear production in millimetres.

  2. TBUT:(to test tear film stability and Meibomian gland disorder) Fluorescein TBUT is one of the measures of tear film stability. It is performed by moistening a fluorescein strip with sterile non-preserved saline and applying it to the inferior tarsal conjunctiva. The precorneal tear film is examined using a broad beam of the slit lamp with a blue filter. The time lapse between the last blink and the appearance of the first randomly distributed dark discontinuity in the fluorescein stained tear film is the TBUT. Breakup times less than 10 s are considered abnormal.

  3. OSDI (Ocular Surface Disease Index)  questionnaire: This is used to assess the ocular symptoms associated with dry eye disease from symptoms to visual disturbances. The 12-item questionnaire assesses dry eye symptoms and the effects it has on vision-related function in the past week of the patient’s life. The questionnaire has 3 subscales: ocular symptoms, vision-related function, and environmental triggers. Patients rate their responses on a 0 to 4 scale with 0 corresponding to “none of the time” and 4 corresponding to “all of the time.” A final score calculated ranges from  0 to 100 with scores 0 to 12 representing normal, 13 to 22 representing mild dry eye disease, 23 to 32 representing moderate dry eye disease, and greater than 33 representing severe dry eye disease.

  4. Lissamine green staining of cornea and conjunctiva:conjunctival staining using lissamine green was observed at least 1 minute but no more than 4 minutes after the instillation of dye through slit-lamp examination under dimmed white light.

 
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