| 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
|
|
|
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
|
|
|
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 |