| CTRI Number |
CTRI/2020/09/027637 [Registered on: 07/09/2020] Trial Registered Prospectively |
| Last Modified On: |
05/05/2021 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Monofocal Extended Depth of Focus Intraocular Lens for the Correction of Aphakia |
|
Scientific Title of Study
|
A Comparative Clinical Evaluation of the Safety and Effectiveness of a Monofocal Extended Depth of Focus Intraocular Lens for the Correction of Aphakia |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AVSCP7979, dated:20/12/2019 |
Protocol Number |
| CI/MD/2020/000004 |
DCGI |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Jamuna AS |
| Designation |
Consultant Phaco Surgeon |
| Affiliation |
Sri Ramchandra Eye Hospital |
| Address |
Sri Ramchandra Eye Hospital
No 15, Good Shed St,
Madurai, Tamil Nadu 625001, India
Madurai
TAMIL NADU
625 001
India |
| Phone |
9944599195 |
| Fax |
|
| Email |
krishjamuna@yahoo.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Prabhakar Kolamuri |
| Designation |
Sr. Director-Clinical Operations |
| Affiliation |
Hingeclinica Pvt Ltd |
| Address |
Cyber Towers, Quadrant-4, Second floor, Hitech City, Hyderabad, Telangana-500081, India
Hyderabad
TELANGANA
500081
India |
| Phone |
9741766881 |
| Fax |
|
| Email |
prabhakar.kolamuri@hingeclinica.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Laxman Jakkala |
| Designation |
Sr. Director - Quality & Regulatory |
| Affiliation |
Hingeclinica Pvt Ltd |
| Address |
Cyber Towers, Quadrant-4, Second floor, Hitech City, Hyderabad, Telangana-500081, India
Hyderabad
TELANGANA
500081
India |
| Phone |
9000782176 |
| Fax |
|
| Email |
laxman.jakkala@hingeclinica.com |
|
|
Source of Monetary or Material Support
|
| Advanced Vision Science Inc,
(A Santen Company)
5743 Thornwood Dr.
Goleta, CA 93117, U.S.A. |
|
|
Primary Sponsor
|
| Name |
Advanced Vision Science Inc |
| Address |
(A Santen Company)
5743 Thornwood Dr.
Goleta, CA 93117, U.S.A. |
| Type of Sponsor |
Other [device development company] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Tatvam Research LLC |
Krishna Kumar Venkateswaran,
10 Fallbrook, Irvine, CA 92604. USA. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Jamuna AS |
Sri Ramchandra Eye Hospital |
15, Good Shed Street, Madurai - 625001, Tamil Nadu, India.
Madurai
TAMIL NADU |
04522340832
krishjamuna@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Asirvatham Speciality Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H268||Other specified cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Monofocal Extended Depth of Focus Intraocular Lens, Model ME4 |
Permanent implant in both eyes. |
| Intervention |
Monofocal Extended Depth of Focus Intraocular Lens, Model ME6 |
Permanent implant in both eyes. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Adults 40 years of age and older at the time of consent.
2. Cataract in both eyes.
3. Pre-operative corneal astigmatism < 1.0 D.
4. Calculated lens power from 18 D to 24 D.
5. Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months.
6. Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by manual phacoemulsification cataract extraction in both eyes.
7. Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery.
8. Preoperative best corrected distance visual acuity (BCDVA) of 0.2 logMAR or worse, with or without a glare source.
9. Post-operative BCDVA projected to be 0.2 logMAR or better (as determined by the medical judgment of
the Investigator or measured by potential acuity meter / retinal acuity meter (PAM / RAM) if necessary).
10. Pharmacologically dilated pupil size at least 6.0 mm.
11. Must be able to understand and provide informed consent themselves or through a representative with a
witness present on the IRB or EC approved Informed Consent Form (ICF). |
|
| ExclusionCriteria |
| Details |
1. Participation in any other drug or device clinical trial within 90 days prior to enrolling in this study and/or during study participation.
2. Pregnancy or lactation.
3. Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms - CRF).
4. Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
5. History of any intraocular or corneal surgery in either eye (including LASIK, PRK, LRI, etc.).
6. Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye.
7. Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis, aniridia, rubeosis iridis, clinically significant corneal, Fuchs,anterior membrane distrophis,etc) in either eye.
8. Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
9. Any visually significant intraocular media opacity other than cataract in either eye.
10. History of any clinically significant retinal pathology or ocular diagnosis (e.g., diabetic retinopathy, ischemic
disease, macular degeneration, retinal detachment, amblyopia, optic neuropathy, microphthalmos, aniridia,
etc.) in either eye that could alter or limit final postoperative visual prognosis.
11. History of cystoid macular edema in either eye.
12. Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements.
13. Uncontrolled glaucoma in either eye.
14. Extremely shallow anterior chamber (< 2.0 mm).
15. Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes.
16. Irregular astigmatism, corneal degeneration or dystrophy.
17. Uncontrolled systemic disease (e.g., diabetes mellitus, active cancer treatment, mental illness, etc.) in the opinion of the investigator, would put the subjects health at risk and/or prevent the subject from completing all study visits.
18. Systemic medication that, in the opinion of the investigator, may confound the outcome or increase the intraoperative and post-operative risk to the subject (e.g., Tamsulosin Hydrochloride) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g., small pupil/floppy iris syndrome).
19. Subjects who may reasonably be expected to require any additional ophthalmic surgical intervention at any
time during the study (other than YAG capsulotomy).
20. Need for concomitant procedures (e.g., glaucoma surgery, LRI, RK, LASIK, etc.).
21. Subjects with central endothelial cell density <2000 cells/mm2
.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Monocular Uncorrected Distance Visual Acuity at Form 4A. |
80 - 100 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
- Monocular Distance Corrected Intermediate Visual Acuity at Form 4A
- Monocular Uncorrected Intermediate Visual Acuity at Form 4A |
80- 100 days |
|
|
Target Sample Size
|
Total Sample Size="55"
Sample Size from India="55"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/09/2020 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Subjects scheduled to undergo cataract extraction and intraocular lens implantation will be screened for eligibility. Eligible subjects will be examined preoperatively to obtain a medical history and to establish a baseline ocular condition. Subjects will be randomized in a 1:1 ratio and undergo small incision phacoemulsification cataract surgery and implantation with either the Mono-EDoF IOL Model ME4 or ME6 in the primary eye. Second eye surgery will occur at least two weeks following first eye surgery. Postoperatively, subjects will undergo a complete ophthalmic evaluation at regularly scheduled intervals. |