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CTRI Number  CTRI/2018/04/013238 [Registered on: 13/04/2018] Trial Registered Retrospectively
Last Modified On: 07/04/2018
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing three frequencies for phacoemulsification for cataract 
Scientific Title of Study   Comparison of effective phacoemulsification time and corneal endothelial cell loss using three different ultrasound frequencies in phacoemulsification 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Praveen Kumar Malik  
Designation  Professor Ophthalmology 
Affiliation  PGIMER & RMLHospital  
Address  Room No. 66, Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9810405681  
Fax    
Email  praveenk002@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Taru Dewan 
Designation  Professor Ophthalmology  
Affiliation  PGIMER & RMLHospital 
Address  Room No. 58A, Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9810673180  
Fax    
Email  tarudewan@hotmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Nisha Bharti 
Designation  post graduate student  
Affiliation  PGIMER & RMLHospital 
Address  Room No. 66, Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg New Delhi

Central
DELHI
110001
India 
Phone  9013617207  
Fax    
Email  drnisha008@gmail.com  
 
Source of Monetary or Material Support  
PGIMER & RMLHospital, Baba Kharak Singh Marg New Delhi 110001  
 
Primary Sponsor  
Name  Dr Praveen Kumar Malik 
Address  PGIMER & RMLHospital, New Delhi 
Type of Sponsor  Other [Principal investigator] 
 
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 Praveen Kumar Malik  PGIMER & DR RMLHospital  Room no 66,Eye Department,PGIMER & Dr RMLHospital,Baba Kharak Singh Marg, New Delhi Central DELHI
Central
DELHI 
9810405681

praveenk002@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, Dr RMLHospital   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  cataract,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  28 KHz frequency ultrasound  phacoemulsification using 28 KHz  
Comparator Agent  42 KHz frequency ultrasound  phacoemulsification using 42KHz 
Intervention  53 KHz frequency ultrasound   phacoemulsification using 53KHz  
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Patients of age >40 yrs having Grade 4.0-6.9 (LOCS III grading) of senile cataract

2. Patients willing to participate in the study with written consent
 
 
ExclusionCriteria 
Details  1. Patients with pre-operative endothelial cell density count less than 1500 cells/mm2 .

2. Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading
3. Raised intraocular pressure (> 21 mmHg)

4. Previous intraocular surgery
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
EFFECTIVE PHACOEMULSIFICATION TIME
 
Peroperative
 
 
Secondary Outcome  
Outcome  TimePoints 
TOTAL ULTRASOUND TIME
 
PER OPERATIVE 
Endothelial Cell Density(CD)   Preoperatively,1 week, 1 month,3 months, 6 months ,9 months, 1 year 
Coefficient of variation of cell size(CV)   Preoperatively,1 week, 1 month,3 months, 6 months ,9 months, 1 year 
Central Corneal Thickness(CCT)  Preoperatively,1 week, 1 month,3 months, 6 months ,9 months, 1 year 
Hexagonal Cell Count(6A)  Preoperatively,1 week, 1 month,3 months, 6 months ,9 months, 1 year 
Intraocular Pressure  Preoperatively,1 week, 1 month 
Best Corrected Visual Acuity  Preoperatively,1 week, 1 month 
 
Target Sample Size   Total Sample Size="165"
Sample Size from India="165" 
Final Enrollment numbers achieved (Total)= "165"
Final Enrollment numbers achieved (India)="165" 
Phase of Trial   Phase 3/ Phase 4 
Date of First Enrollment (India)   01/12/2016 
Date of Study Completion (India) 28/02/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   not yet published 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

Phacoemulsification is today the most popular surgery for cataract worldwide. The nucleus is emulsified using a machine which provides energy for emulsifying the nucleus and generates a vacuum for aspirating the cortex. The method is constantly being improved to minimize the risk of complications, particularly tearing of the capsule and dropping of the nucleus into the vitreous ,and corneal endothelial damage.1 Effective phaco time is time taken to remove cataract if continuous 100% phaco power is used. Lower the effective phaco time, lower the energy delivered in the eye and thus clearer the cornea with better visual rehabilitation.2

 

Phacoemulsification is ultrasound based dissolution of lens matter. The piezoelectric crystal imparts a specific frequency vibratory motion to the phaco tip which when interacts with the lens matter in a fluid based environment leads to disintegration and dissolution of the cataractous lens. It is in accordance with the principles of physics that subjecting a solid to a frequency matching its internal resonant frequency would lead to disintegration of intermolecular bonds and make it easily aspirable. Biological experiments have shown supporting evidence in other human tissue.3

 

Increasing hardness of cataract is associated with change in chemical and physical properties in the crystalline lens and should logically require a change in frequency of ultrasound. However different machines, though within the range of 22-60 kHz, use the same frequency ultrasound (inherent to the machine) for all grades of cataract and hence end up with higher effective phaco time in hard cataract.4

 

Higher effective phaco time is associated with increase in endothelial damage5and using optimal frequency should reduce effective phaco time and hence corneal endothelial loss during phaco. So far the studies have compared machines with different frequencies in cataract but unique phacodynamics of each machine brings in other confounding variables making the results questionable. In a pilot study we found lower effective phaco time with use of higher frequency ultrasound6. Based on these results an RCT was conducted after ethical approval comparing 28 and 42 kHz frequencies in the same machine Megatron S4. The result showed decrease in effective phaco time and endothelial cell loss with use of higher frequency. The present Geuder

 

Megatron S4 HPS phaco machine delivers ultrasound frequency range from 27-55 kHz. We wish to conduct a randomized controlled trial comparing three frequencies 28kHz, 42kHz, and 55kHz in the same machine in patients with identical parameters and see if we arrive at statistically significant results through the comparison.

 

RESEARCH QUESTION

 

 Is there any difference in effective phaco time and endothelial cell loss between three different ultrasound frequencies in phacoemulsification?

HYPOTHESIS

There is difference in effective phaco time and endothelial cell loss between three different ultrasound frequencies in patients of cataract undergoing phacoemulsification

 
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