| CTRI Number |
CTRI/2019/08/020754 [Registered on: 19/08/2019] Trial Registered Prospectively |
| Last Modified On: |
16/08/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [INTRAOCULAR LENS] |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A prospective clinical study to compare the safety and efficacy of three different distance vision correcting water repelling intraocular lenses implanted after cataract surgery |
|
Scientific Title of Study
|
A prospective,randomized comparative clinical study to compare the safety and efficacy of different Hydrophobic Aspheric Monofocal Intraocular lenses |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NOT APPLICABLE |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and MD Nethradhama superspeciality eye hospital |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
#256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and MD Nethradhama superspeciality eye hospital |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
#256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sri Ganesh |
| Designation |
Chairman and MD Nethradhama superspeciality eye hospital |
| Affiliation |
Nethradhama superspeciality eye hospital |
| Address |
#256/14, Kanakapura main road, 7th block Jayanagar, Bangalore-560082
Bangalore
KARNATAKA
560082
India |
| Phone |
|
| Fax |
|
| Email |
phacomaverick@gmail.com |
|
|
Source of Monetary or Material Support
|
| BIOTECH OPHTHALMICS PVT. LTD Block 1, Abhishree Corporate Park, Opp Swagat bunglow BRTS stop Bopal- Ambli road Ahmedabad -380058, Gujarat, India |
|
|
Primary Sponsor
|
| Name |
Biotech healthcare Pvt Ltd |
| Address |
Block 1 Abhishree Corporate Park Opp Swagat bungalow BRTS stop Bhopal Ambli Road Ahmedabad 380 058 Gujarat India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
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 Sri Ganesh |
Nethradhama superspeciality eye hospital |
Phaco-refractive department,2nd floor, OPD block, #256/14,Kanakapura main road, Jayanagar 7th block, Bengaluru,Karnataka 560082
Bangalore
KARNATAKA |
9845129740
phacomaverick@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ethics committee for research on human subjects |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Eyecryl plus ASHFY600 |
Implantation of Eyecryl plus ASHFY600 patients undergoing cataract surgery and compare its safety and efficacy with Optiflex genesis and Tecnis 1 |
| Intervention |
Optiflex Genesis hydrophobic aspheric monofocal intraocular Lens |
Implantation of Optiflex genesis,a hydrophobic aspheric monofocal lens in patients undergoing cataract surgery and evaluate its safety and efficacy and compare it with other hydrophobic aspheric monofocal IOLs Tecnis 1 and Eyecryl plus ASHFY600 |
| Comparator Agent |
Tecnis 1 |
Implantation of Tecnis 1 in patients undergoing cataract surgery and compare its safety and efficacy with Optiflex genesis and Eyecryl plus ASHFY600 |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
age 18 and older
Best corrected visual acuity to be 0.2 logmar or lower
cataract
calculated IOL power within range of investigational IOL
subjects are willing and understand and sign informed consent
subjects are willing and able to attend postoperative examinations as per schedule |
|
| ExclusionCriteria |
| Details |
previous intraocular and corneal surgery
pregnancy and lactation
traumatic cataract
concurrent participation in another drug or device study
chronic uveitis
patients receiving chloroquine treatment
corneal dystrophy or endothelial insufficiency
microphthalmia
active ocular diseases( active diabetic retinopathy, uncontrolled glaucoma) |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, fixed |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the visual outcomes, contrast sensitivity and patient satisfaction after IOL implantation
Uncorrected visual acuity
best corrected visual acuity
contrast sensitivity |
Time-frame: pre-op, 1,7, 30,90,180 and 365 days follow up |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
high order aberrations
manifest refraction
defocus curve corrected upto 4D
fundus visualisation
PCO
IOP
IOL discolouration
adverse event |
pre-op, intra op, 1,7, 30,90,180 and 365 days follow up |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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
|
N/A |
|
Date of First Enrollment (India)
|
19/08/2019 |
| 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="9"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
1.Montes-Mico R, Ferrer-Blasco T, Cervi no A. Analysis of the possible benefits of aspheric intraocular lenses: review of the literature. J Cataract Refract Surg 2009; 35:172–181 2.Belluci R, Morselli S. Optimizing higher-order aberrations with intraocular lens technology. 2007;18(1):67-73 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective, randomised, single centre, comparative clinical study to evaluate the safety and efficacy ( visual outcomes, contrast sensitivity and patient satisfaction) of different hydrophobic aspheric monofocal intraocular lenses on patients, 18 years and older, undergoing cataract surgery fulfilling the inclusion criteria and who are willing to participate in the clinical trial. Optiflex genesis, Eyecrylplus ASHFY600 and Tecnis 1 are the three investigational IOLs being used in the study. Sample size of 168 eyes (56 eyes in each arm) considering 20% drop out rate is required to prove the null hypothesis mean change in BCVA for all the three investigational products are same vs the alternative hypothesis of unequal mean change in BCVA. |