| CTRI Number |
CTRI/2022/11/047565 [Registered on: 23/11/2022] Trial Registered Prospectively |
| Last Modified On: |
16/11/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Visual Outcomes following implantation of a extended vision IOL in patients with early macular degeneration
|
|
Scientific Title of Study
|
" Visual Outcomes Following Implantation Of A Wave Front Shaping IOL In Patients With Early Age-related Macular Degeneration: A Prospective, interventional Case Series Study†|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
201, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT
380052
India
Ahmadabad GUJARAT 380052 India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
201, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT
380052
India
Ahmadabad GUJARAT 380052 India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Abhay R Vasavada |
| Designation |
Director |
| Affiliation |
Raghudeep Eye Hospital |
| Address |
201, Cataract Department, Raghudeep Eye Hospital, Near Shreeji Complex, Gurukul Road, Memnagar Ahmadabad GUJARAT 380052 India
Ahmadabad
GUJARAT
380052
India Ahmadabad GUJARAT 380052 India |
| Phone |
|
| Fax |
|
| Email |
icirc@abhayvasavada.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Alcon Laboratiores USA |
| Address |
6201 , South freeway ,Fort Worth , Texas 76134 |
| Type of Sponsor |
Other [Surgical Industry Global] |
|
|
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 Abhay R Vasavada |
Raghudeep Eye Hospital |
Gurukul Road, Memnagar, Ahmedabad-380052
Ahmadabad
GUJARAT Ahmadabad GUJARAT |
079-40400909
icirc@abhayvasavada.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Iladevi Cataract & IOL Research Centre Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H250||Age-related incipient cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cataract Surgery with vivity IOL implantation |
SINGLE SURGICAL INTERVENTION |
| Comparator Agent |
Target refraction mini monovision |
Cataract Surgery with vivity IOL implantation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients with uncomplicated, age related cataracts and nuclear sclerosis ranging from grade I to IV on the LOCS III grading system and pre-existing stable, early dry age-related macular degeneration. Early dry AMD will be defined based on the AREDS 2 study criteria (i.e. Multiple small drusen <63 microns or few intermediate drusen >63 - <125 microns, or pigmentary changes at macula). Only one eye of each patient will be included.
|
|
| ExclusionCriteria |
| Details |
Choroidal neovascularization, severe dry AMD, large drusen, foveal thickness >300 microns on optical coherence tomography (OCT), macular hole on OCT, prior history of intravitreal injection / implant, other ocular comorbidities including but not limited to glaucoma, uveitis, pseudoexfoliation syndrome, zonular weakness, macular pathology, diabetic retinopathy, ocular coloboma etc. nonreactive or irregular pupil, prior ocular surgery or trauma. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Unaided and corrected distance visual acuity (LogMAR) at
4 metres on the ETDRS chart |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Unaided and corrected distance visual acuity (LogMAR) at
4 metres on the ETDRS chart |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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)
|
01/12/2022 |
| 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="6" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
To be published after study completion |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Presbyopia correction in conjunction with cataract
surgery has been the holy grail for cataract surgeons. Today, several
multifocal (bifocal / trifocal) IOLs are available that give excellent unaided
visual acuity for distance, intermediate and near vision activities. However,
inherent compromises of photic phenomena and reduction in contrast sensitivity
often mar the successful visual outcomes of diffractive multifocal IOLs. This
has been a concern, particularly in eyes with pre-existing early, stable
macular degeneration. More surgeons today prefer monofocal IOL implantation in
eyes with mild retinal compromise, including early dry macular degeneration. However,
recently, the non-diffractive extended range of vision IOL (Vivity) has been
launched. It provides greater spectacle independence compared to monofocal IOLs
and available reports show minimal to no photic phenomena as well as contrast
sensitivity reduction. However, it is not yet clear whether the Vivity IOL will
offer a comparable quality of distance vision and a greater range of vision
without significant compromise in the quality of vision in eyes with early dry
macular degeneration. The aim of this study is to evaluate unaided and best
corrected visual acuity at different distances and varying contrast levels. |