| CTRI Number |
CTRI/2024/05/067844 [Registered on: 24/05/2024] Trial Registered Prospectively |
| Last Modified On: |
24/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Safety and Efficacy of a New Enhanced Monofocal Intraocular Lens |
|
Scientific Title of Study
|
Evaluation of Visual Outcomes and Quality of Vision following Implantation of a New Enhanced Monofocal Intraocular Lens |
| 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 Supriya Sriganesh |
| Designation |
Senior Phacorefractive Surgeon |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Room number 034, Phacorefractive department, OPD division, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
|
| Fax |
|
| Email |
dr.supriyasriganesh@nethradhama.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Karanam Dhatri |
| Designation |
Phacorefractive fellow |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9052188216 |
| Fax |
|
| Email |
k.dhatri90@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Karanam Dhatri |
| Designation |
Phacorefractive fellow |
| Affiliation |
Nethradhama Super Speciality Eye Hospital |
| Address |
Nethradhama Super Speciality Eye Hospital, Phacorefractive Department, OPD Division, Room number 202,256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA
560070
India |
| Phone |
9052188216 |
| Fax |
|
| Email |
k.dhatri90@gmail.com |
|
|
Source of Monetary or Material Support
|
| Nethradhama Super Speciality Eye Hospital, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070 INDIA |
|
|
Primary Sponsor
|
| Name |
Nethradhama Super Speciality Eye Hospital |
| Address |
256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070 |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Karanam Dhatri |
Nethradhama Super Speciality Eye Hospital |
Phacorefractive Department, OPD Division, Room number 034, 256/14, Kanakapura Rd, 7th Block, Jayanagar, Bengaluru, Karnataka 560070
Bangalore
KARNATAKA |
9052188216
k.dhatri90@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Nethradhama Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraocular Lens Implantation |
Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) is a single-piece enhanced monofocal IOL crafted from glistening-free hydrophobic acrylate. After IOL implantation, duration of study is for 3 months post operatively. |
| Comparator Agent |
N/A |
N/A |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Eyes with senile cataract of grades 1-4 Nuclear Sclerosis, Cortical cataracts, Posterior subcapsular cataract
Corneal astigmatism equal to or less than 1D
IOL power between +10D to +30D
In the bag IOL implantation
|
|
| ExclusionCriteria |
| Details |
Eyes with corneal astigmatism more than 1.0 D
Hypermature/morgagnian/intumescent and brunescent cataracts more than NS 4
Corneal disorders like- irregular astigmatism, keratoconus, pellucid marginal degeneration, corneal dystrophy, low endothelial cell counts less than 1500
Pupillary abnormalities
History of glaucoma or intraocular inflammation
Macular disease or retinopathy, neuro-ophthalmic diseases, active infections, previous ocular surgery of any kind, any other ocular pathology.
Intraoperative or postoperative complications
|
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate distance, intermediate and near visual acuity after implantation of Vivinex Impress XY-IM100 (Hoya Surgicals) for age related cataracts. |
Baseline, Post operative day 1, 15 and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate quality of vision by measuring contrast sensitivity, objective scatter index, spherical aberrations, and defocus curve. |
post operative day 1, 15 and 3 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| 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) |
Not Yet Recruiting |
|
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
|
TITLE: Early Visual Outcomes and Quality of Vision following implantation of a New Enhanced Monofocal Intraocular Lens
PURPOSE: To evaluate early visual outcomes, safety and efficacy of a new enhanced monofocal intraocular lens over 3 months.
SETTING: Nethradhama Super Speciality Eye hospital
METHODOLOGY: This is a prospective, single centered, interventional study, in which Vivinex Impress XY1-EM (Hoya Surgical Optics, Singapore) was implanted in 60 eyes. Post operatively on day 15- and 3-months following tests were done. Uncorrected (UDVA) and corrected distance visual acuity (CDVA), manifest sphere, cylinder and Spherical Equivalent (SE), Contrast sensitivity testing (FACT), internal and total aberrations assessment using ray tracing aberrometry, objective scatter index, dilated examination for IOL position, binocular corrected defocus curve using defocusing lenses from +3 to –3D and reading speed using Salzburg reading desk (SRD) at preferred reading and intermediate distance were performed. |