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CTRI Number  CTRI/2020/09/028005 [Registered on: 23/09/2020] Trial Registered Prospectively
Last Modified On: 18/09/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Controlling the dry eye symptoms caused by Femtosecond Cataract surgery with the help of topical lubricants  
Scientific Title of Study   Controlling Dry Eye Disease after Femtosecond Laser Cataract Surgery by use of Topical Lubricants: A Double Blind Randomized Controlled Trial 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Avilasha Mohapatra 
Designation  Junior Resident 
Affiliation  AIIMS Delhi 
Address  Room no 391 3rd floor Dr RP centre for Ophthalmic Sciences Department of Ophthalmology AIIMS New Delhi- 110023
patanjali hostel 19
South
DELHI
110023
India 
Phone  9894339928  
Fax    
Email  avilasha1994@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Avilasha Mohapatra 
Designation  Junior Resident 
Affiliation  AIIMS Delhi 
Address  Room no 391 3rd floor Dr RP centre for Ophthalmic Sciences Department of Ophthalmology AIIMS New Delhi- 110023
patanjali hostel 19
South
DELHI
110023
India 
Phone  9894339928  
Fax    
Email  avilasha1994@gmail.com  
 
Details of Contact Person
Public Query  
Name  Avilasha Mohapatra 
Designation  Junior Resident 
Affiliation  AIIMS Delhi 
Address  Room no 391 3rd floor Dr RP centre for Ophthalmic Sciences Department of Ophthalmology AIIMS New Delhi- 110023
patanjali hostel 19
South
DELHI
110029
India 
Phone  9894339928  
Fax    
Email  avilasha1994@gmail.com  
 
Source of Monetary or Material Support  
Dr R P Centre, AIIMS 
 
Primary Sponsor  
Name  Dr Rajendra Prasad Centre of Ophthalmic Sciences 
Address  AIIMS New Delhi- 110049 
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 
Dr Radhika Tandon  Dr RP centre for ophthalmic sciences, new delhi  AIIMS NEW DELHI
South
DELHI 		 011-26593145

radhika_tan@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
ethics commitee aiims new delhi  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H251||Age-related nuclear cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  using placebo   topical placebo (0.9 % saline) which will be given to other set of patients 1 week before femto second cataract surgery util 3 months post -operatively 
Intervention  using topical lubricants to control dry eye symptoms  topical lubricant will contain 0.5 % carboxymethycellulose and 1 % sodium hyaluronate which will be given to one set of patients 1 week before femtosecond cataract surgery to 3 months post operatively  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  patients who are posted for femtosecond laser cataract surgery 
 
ExclusionCriteria 
Details  1 pre-operative dry eyes
2 contact lens wear
3 disorders of lid and nasolacrimal gland
4 history of smoking
5 ocular allergy
6 systemic disease like sjogrens, diabetes mellitus 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
OSDI SCORE13
 		 1st week, 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
NIBUT10 SECONDS
OCULAR SURFACE STAINING 5 CORNEAL SPOTS AND 14 CONJUNCTIVAL SPOTS
PRESENCE OF INFLAMMATORY MARKERS IN TEAR LIKE TNF ALPHA AND IL 1 BETA 		 1 st week, 3 months 
 
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)   30/09/2020 
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 - NO
Brief Summary   The patients who meet the inclusion criteria will be administered written Informed Consent, after which he/she undergoes pre-op history, examination, IOL workup and the inflammatory markers in tears are done. After which they are randomly divided into 2 groups- 20 in treatment and 20 in control group. Topical lubricants is given to the treatment group and placebo drops (0.9% saline) is given to the control group patients 3 day prior to the surgery along with standard pre-operative medications. After which all the patients undergo femtosecond laser cataract surgery. Post-operative history, examination and dry eye evaluation done at day 1, 1st week and 1st month and 3rd month. Tear inflammatory markers will be  evaluated at 1 month post op. Along with the standard post-operative medications, the treatment group would receive topical lubricants and the control group would receive placebo drops. Patients who develop dry eye symptoms/signs during the study period will be additionally treated with HPMC 0.5 % QID and response noted. Treatment code will be broken at end of the study.  
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