| CTRI Number |
CTRI/2024/04/065721 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
09/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [dynamic infusion technique in phacoemulsification surgery i] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the phacoemulsification cataract extraction with infusion pressure system and gravity. |
|
Scientific Title of Study
|
A Randomized Controlled Clinical Study Evaluating Adaptive fluidics with dynamic fluid infusion boosts efficiency of phacoemulsification. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Dr Lional Raj D |
| Designation |
Regional Medical Director |
| Affiliation |
Dr. Agarwals Eye Hospital |
| Address |
Dept. of Cataract & IOL,
Dr. Agarwals Eye Hospital,
15, South Bypass Road Vannarpettai Tirunelveli
Tirunelveli
Tirunelveli
TAMIL NADU
627003
India |
| Phone |
8754411261 |
| Fax |
|
| Email |
drlionalraj@dragarwal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Dr Lional Raj D |
| Designation |
Regional Medical Director |
| Affiliation |
Dr. Agarwals Eye Hospital |
| Address |
Dept. of Cataract & IOL,
Dr. Agarwals Eye Hospital,
15, South Bypass Road Vannarpettai Tirunelveli
Tirunelveli
Tirunelveli
TAMIL NADU
627003
India |
| Phone |
8754411261 |
| Fax |
|
| Email |
drlionalraj@dragarwal.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof Dr Lional Raj D |
| Designation |
Regional Medical Director |
| Affiliation |
Dr. Agarwals Eye Hospital |
| Address |
Dept. of Cataract & IOL,
Dr. Agarwals Eye Hospital,
15, South Bypass Road Vannarpettai Tirunelveli
Tirunelveli
Tirunelveli
TAMIL NADU
627003
India |
| Phone |
8754411261 |
| Fax |
|
| Email |
drlionalraj@dragarwal.com |
|
|
Source of Monetary or Material Support
|
| Dr Agarwals Eye Hospital, Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Investigator initiated study |
| Address |
Dr. Agarwals Eye Hospital
15, South Bypass Road Vannarpettai, Tirunelveli 627003, Tamil Nadu, India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Prof Dr Lional Raj D |
Dr. Agarwals Eye Hosptial |
Dept. of Cataract & IOL, No.15, South Bypass Road,
Vannarpettai,
Tirunelveli - 627003
Tirunelveli
TAMIL NADU |
8754411261
drlionalraj@dragarwal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. Agarwal’s Eye Hospital Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adaptive Fluidics |
Variable infusion pressure system used in phacoemulsification procedure to maintain the fluidics stability within the eye. |
| Comparator Agent |
Gravity fed fixed infusion pressure system |
Infusion of fluid through gravity system used in phacoemulsification procedure to maintain the fluidics stability within the eye. |
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Cataract grade 2 - 3.
Calculated Axial length 22 to 24 mm.
Pupil size on dilation more than 6.5 mm.
Given consent to use device related data for scientific purpose.
Clear intraocular media other than cataract.
Patient willing to participate and sign informed consent. |
|
| ExclusionCriteria |
| Details |
Previous intraocular or corneal surgery.
Traumatic cataract.
Irregular astigmatism.
Instability of keratometry or biometry measurements.
Patient having Microphthalmia.
Patient having Chronic Uveitis.
Patient suffering from corneal dystrophy or endothelial insufficiency.
Patient having active ocular diseases (active diabetic retinopathy, uncontrolled glaucoma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Used Fluid Volume within the eye |
Intraoperative |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Average Phaco Power, Absolute Phaco Time, Elapsed Phaco Time |
Intraoperative |
|
|
Target Sample Size
|
Total Sample Size="108"
Sample Size from India="108"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Maintaining
a stable intraocular pressure while doing phacoemulsification surgery by using gravity infusion may
result in pressure variation, sometimes high and, that could result in damaging of intraocular tissues
such as the cornea, iris and optic nerve, and induce pain or discomfort to the
patient.
Purpose: The key phacoemulsification attributes of fluid
volume and ultrasound parameters between variable infusion pressure system
(adaptive fluidics) and gravity fed fixed infusion pressure system.
|