| CTRI Number |
CTRI/2024/02/062688 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
27/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical study of EYECRYLâ„¢ PLUS (600) intraocular lens in patients undergoing cataract surgery |
|
Scientific Title of Study
|
Prospective, single arm, post-marketing clinical study of EYECRYLâ„¢
PLUS (600) intraocular lens to assess performance and safety in patients
undergoing cataract surgery.
|
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR UDAY GAJIWALA |
| Designation |
Superintendant |
| Affiliation |
Tejas eye hospital |
| Address |
Office number 1, Ground floor,Tejas Eye Hospital Run by Divyajyoti Trust Suthar Falia Opp Hanuman Temple
At Po Mandvi Dist Surat 394160
Surat
GUJARAT
394160
India |
| Phone |
9426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR UDAY GAJIWALA |
| Designation |
Superintendant |
| Affiliation |
Tejas eye hospital |
| Address |
Office number 1, ground floor Tejas Eye Hospital Run by Divyajyoti Trust Suthar Falia Opp Hanuman Temple
At Po Mandvi Dist Surat 394160
GUJARAT
394160
India |
| Phone |
9426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR UDAY GAJIWALA |
| Designation |
Superintendant |
| Affiliation |
Tejas eye hospital |
| Address |
Office number 1, ground floor, Tejas Eye Hospital Run by Divyajyoti Trust Suthar Falia Opp Hanuman Temple
At Po Mandvi Dist Surat 394160
GUJARAT
394160
India |
| Phone |
9426125947 |
| Fax |
|
| Email |
divyajyoti.icare@gmail.com |
|
|
Source of Monetary or Material Support
|
| Biotech vision care pvt ltd,Block 1, Abhishree Corporate Park, Opp. Swagat Bunglow, BRTS Stop
Bopal - Ambli Road, Ahmedabad - 380 058 Gujarat India
|
|
|
Primary Sponsor
|
| Name |
Biotech vision care pvt ltd |
| Address |
Block 1 Abhishree Corporate Park Opp Swagat Bunglow BRTS Stop
Bopal Ambli Road Ahmedabad 380 058 Gujarat India
|
| Type of Sponsor |
Other [Medical device industry] |
|
|
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 Uday Gajiwala |
Tejas eye Hospital |
Office number 4 clinical trial department, Ground floor, Tejas Eye Hospital Run by Divyajyoti Trust
Suthar Falia, Opp. Hanuman Temple,
At & Po. Mandvi, Dist. : Surat - 394160
Surat
GUJARAT |
09426125947
divyajyoti.icare@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee divyajoti trust tejas eye hospital |
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 |
EYECRYLâ„¢ PLUS (600),
Monofocal Hydrophillic Acrylic
Foldable Intraocular Lens. |
Eyecryl hydrophilic intraocular
lenses (IOL) are acrylic foldable
single piece & multi-piece
posterior chamber IOLs. These
IOLs are designed to be
surgically implanted in the
human eye as a replacement for
the natural crystalline lens.
These IOLs are made from
medical implantable grade
hydrophilic material with 26%
water content. Refractive index
of 1.46 at 35°C. hydrophilic NY
incorporates natural yellow
chromophore which absorbs the
UV light and filter violet light.
The study duration is 42 months |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
1. Age 18 year or greater
2. Cataract
3. Calculated IOL power is within the range of the
investigational IOL.
4. Clear intraocular media other than cataract
5. Patient willing to participate and sign informed consent to
participate in study and to use device related data for
scientific purpose
6. Patient willing to come for all post-operative follow-up
7. Female participants of child bearing potential and male
participants whose partner is of child bearing potential must
be willing to ensure that they or their partner use effective
contraception during the study. |
|
| ExclusionCriteria |
| Details |
1. Previous intraocular or corneal surgery
2. Traumatic cataract
3. Pregnancy
5. Vulnerable subject.
6. Patients receiving chloroquine treatment.
7. Patient having Microphthalmia.
8. Patient having Chronic Uveitis.
9. Patient suffering from corneal dystrophy or endothelial
insufficiency.
10. Patient having active ocular diseases (active diabetic
retinopathy, uncontrolled glaucoma |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of eyes that will achieve distance
uncorrected visual acuity within (0.3 logMAR or
better) at 180 days post operatively.
|
Percentage of eyes that will achieve distance
uncorrected visual acuity within (0.3 logMAR or
better) at 180 days post operatively.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess safety of EYECRYLâ„¢ PLUS 600
intraocular lens in patients undergoing cataract
surgery.
|
Time frame: Preoperative, 7-14 days, 30-60
days, 120-180 days, 330-420 days, 630-780
days and 990-1140 days post operatively. |
|
|
Target Sample Size
|
Total Sample Size="850"
Sample Size from India="850"
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)
|
15/03/2024 |
| 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="4"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
|
The objectives of this study are to evaluate safety and performance of EYECRYLâ„¢ PLUS (600), a
Monofocal Hydrophillic clear Acrylic Foldable Intraocular Lens in patients undergoing cataract
surgery, to evaluate monocular uncorrected distance visual acuity (UCVA) and distance corrected
visual acuity (BCVA) under photophic conditions and to measure the Contrast Sensitivity |