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CTRI Number  CTRI/2018/03/012388 [Registered on: 07/03/2018] Trial Registered Prospectively
Last Modified On: 04/03/2018
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   Role of frequency in surgery for hard cataracts 
Scientific Title of Study   A comparative evaluation of three different ultrasound frequencies for phacoemulsification of hard cataract  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Taru Dewan 
Designation  Professor Ophthalmology 
Affiliation  PGIMER & RMLHospital 
Address  Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg New Delhi

New Delhi
DELHI
110001
India 
Phone  9810673180  
Fax    
Email  tarudewan@hotmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Praveen Kumar Malik 
Designation  Professor Ophthalmology  
Affiliation  PGIMER & RMLHospital 
Address  PGIMER & RMLHospital Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg New Delhi

New Delhi
DELHI
110001
India 
Phone  9810405681  
Fax    
Email  praveenk002@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr Preeti Tomar 
Designation  Post Graduate Student  
Affiliation  PGIMER & RMLHospital 
Address  Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg New Delhi

New Delhi
DELHI
110001
India 
Phone  9711418066  
Fax    
Email  tomarpreeti45@gmail.com  
 
Source of Monetary or Material Support  
PGIMER & DR RML Hospital 
 
Primary Sponsor  
Name  Dr Taru Dewan 
Address  Eye Department PGIMER & RMLHospital Baba Kharak Singh Marg 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 Taru Dewan  PGIMER & DR RMLHospital  Eye Department,BABA KHARAK SINGH MARG, NEW DELHI 110001
New Delhi
DELHI 
9810673180

tarudewan@hotmail.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  Grade 5.6-6.9 (LOCS III grading) of senile cataract 
 
ExclusionCriteria 
Details  1. Patients with pre-operative endothelial cell density count less than 1500 cells/mm2

2. All eye diseases that can compromise the visual recovery.
3. Eyes with any kind of corneal dystrophy or corneal scars preventing visualisation of cataract for reliable grading

4. Raised intraocular pressure (> 21 mmHg)
5. Previous intraocular surgery
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Effective Phacotime   Peroperative 
 
Secondary Outcome  
Outcome  TimePoints 
Endothelial Cell Density(CD)  Preoperatively,1 week, 1 month,3 months, 6 months 
Coefficient of variation of cell size(CV)   Preoperatively,1 week, 1 month,3 months, 6 months 
Central Corneal Thickness(CCT)  Preoperatively,1 week, 1 month,3 months, 6 months 
Hexagonal Cell Count(6A)  Preoperatively,1 week, 1 month,3 months, 6 months 
Intraocular Pressure  one week, one month 
Best Corrected Visual Acuity  one week, one month 
 
Target Sample Size   Total Sample Size="207"
Sample Size from India="207" 
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   Phase 4 
Date of First Enrollment (India)   16/03/2018 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
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 the most commonly used procedure in the cataract surgery.1 It uses high intensity ultrasound energy for fragmentation and emulsification of the lens. With advancement of  surgical devices and techniques the safety and efficacy index of the procedure has increased dramatically.

 However, higher grades of cataract require higher ultrasound energy resulting in more effective phaco time (EPT) and greater corneal endothelial cell density loss (ECDL). The aim is to remove cataract efficiently with highest safety to the eye i.e. lowest incidence of per-op and post-op complications.

For per-op evaluation of any phaco modality the amount of energy used is assessed. Effective Phaco Time is defined as total time taken to surgically remove the cataract using continuous 100% phaco power.

Higher effective phaco time thus leads to many other complications of phacoemulsification, most common of which is endothelial cell density loss.2,3 Therefore using optimal frequencies for hard cataract is most important.

The thickness and corneal transparency are maintained by a barrier function and active fluid pump action of endothelial cells.4 Intraocular manipulations during phacoemulsification and fluid and lens fragment turbulence may lead to endothelial cell damage.5

 An evaluation of ECDL is an important parameter to assess corneal endothelial insult during the procedure.

 Basically, 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.6

As the hardness of lens increases, the physical and chemical properties of lens also change and thus require change in frequency. However different machines though in range of 22-55 KHz use same ultrasonic frequency for higher grades of cataract hence increasing the effective phaco time of phacoemulsification.1,7,8

        In a pilot study, conducted at this institution we found lower effective phaco time with use of higher frequency ultrasound.3

Based on the results of the same, a registered trial was conducted which proved that use of 42 KHz frequency lowered the EPT and protected the endothelium more than 28 KHz in moderate and hard cataract.9

Another study evaluating the use of 28 KHz, 42 KHz, 53 KHz has shown lower EPT with 53 KHz.

The ultrasound energy and time needed in hard cataract is more as compared to soft cataract thus leading to more risk of surgical induced trauma and more corneal endothelial dysfunction. Lower energy is delivered in the eye if effective phaco time is less thus leading to clearer cornea with better visual rehabilitation.10

Hence, this study is being conducted in Hard cataract (LOCS III Grade 5.6-6.9) comparing the effect of  higher frequency on per-op and post-op parameters esp. EPT and ECDL to enable us to choose ideal frequency for these cases.

 

  RESEARCH QUESTION

 

 Is there any difference in effective phacoemulsification time and endothelial cell density loss between three different ultrasound frequencies in Hard Cataract (LOCS III Grade 5.6-6.9)?


 
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