| 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 |
|
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Source of Monetary or Material Support
|
|
|
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
|
|
|
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
|
|
|
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
|
|
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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)?
|
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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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