| CTRI Number |
CTRI/2023/09/057797 [Registered on: 18/09/2023] Trial Registered Prospectively |
| Last Modified On: |
18/09/2023 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A single-center, Investigator Initiated study to check the Visual outcomes and Patient satisfaction after implantation of Vivity intra ocular lens in patients with mild irregular Astigmatism. |
|
Scientific Title of Study
|
A single-center, Prospective, Investigator Initiated, Observational study to evaluate the Visual outcomes and Patient satisfaction after AcrySofVivity IOL implantation in patients with mild irregular Astigmatism. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| DAE-VIOL-2023-001 version 1.0 11 Aug 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ashvin Agarwal |
| Designation |
Executive Director and Chief of Clinical Services |
| Affiliation |
Dr. Agarwals Eye Hospital |
| Address |
Dr Agarwals Eye Hospital Limited, Clinical Research Department, Second Floor, No.222,TTK Road,Alwarpet,
Chennai,Tamil Nadu,India
Chennai
TAMIL NADU
600018
India |
| Phone |
9840430100 |
| Fax |
|
| Email |
agarwal_ashvin@dragarwal.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashvin Agarwal |
| Designation |
Executive Director and Chief of Clinical Services |
| Affiliation |
Dr. Agarwals Eye Hospital |
| Address |
Dr Agarwals Eye Hospital Limited, Clinical Research Department, Second Floor, No.222,TTK Road,Alwarpet,
Chennai,Tamil Nadu,India
TAMIL NADU
600018
India |
| Phone |
9840430100 |
| Fax |
|
| Email |
agarwal_ashvin@dragarwal.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vinod Gyanchandani |
| Designation |
Vice President and Head of Research |
| Affiliation |
Dr. Agarwals Eye Hospital |
| Address |
Dr Agarwals Eye Hospital Limited, Clinical Research Department, Second Floor, No.222,TTK Road,Alwarpet,
Chennai,Tamil Nadu,India
Chennai
TAMIL NADU
600018
India |
| Phone |
9677082432 |
| Fax |
|
| Email |
vinod.gyanchandani@dragarwal.com |
|
|
Source of Monetary or Material Support
|
| Dr Agarwal Eye Hospital Limited |
|
|
Primary Sponsor
|
| Name |
Dr Agarwal Eye Hospital Limited |
| Address |
Dr.Agarwal’s Eye Hospital Limited, Clinical Research Department,
Second Floor, No.222,TTK Road,Alwarpet, Chennai,Tamilnadu,
India
Chennai
TAMIL NADU
600018
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| NIL |
Not Applicable |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ashvin Agarwal |
Dr.Agarwals Eye Hospital |
Dr.Agarwal’s Eye Hospital Limited, Clinical Research Department,
Second Floor, No.222,TTK Road,Alwarpet, Chennai,Tamilnadu,
India
Chennai
TAMIL NADU
600018
India
Chennai
TAMIL NADU |
9840430100
agarwal_ashvin@dragarwal.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr.Agarwal’s Eye Hospital-Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H538||Other visual disturbances, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
None |
Not Applicable |
| Comparator Agent |
None |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult subjects 45 years or older with the normal axial length category (22-25mm) having uncomplicated age-related cataracts and undergoing standard cataract surgery procedure.
2. The subject is willing and able to provide informed consent personally or by a legal representative.
3. Subjects with mild irregular corneal astigmatism defined as mean keratometry values not higher than 47 D, Keratoconus Index (KI) showing Superior-Inferior Asymmetry not higher than 1.4 D, and Surface Regularity Index (SRI) between 0.56 and 1.55. Magnitude of astigmatism 0.0D to <-0.75D only.
4. Central corneal thickness between 520um to 560um.
|
|
| ExclusionCriteria |
| Details |
1. Adult subjects 45 years or older with the normal axial length category (22-25mm) having uncomplicated age-related cataracts and undergoing standard cataract surgery procedure.
2. The subject is willing and able to provide informed consent personally or by a legal representative.
3. Subjects with mild irregular corneal astigmatism defined as mean keratometry values not higher than 47 D, Keratoconus Index (KI) showing Superior-Inferior Asymmetry not higher than 1.4 D, and Surface Regularity Index (SRI) between 0.56 and 1.55. Magnitude of astigmatism 0.0D to <-0.75D only.
4. Central corneal thickness between 520um to 560um.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Monocular BCDVA postoperatively at 3 month |
3 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Monocular UDVA, UIVA, UNVA postoperatively
2.Monocular DCIVA, DCNVA postoperatively
3. Spectacle independence-Patient-Reported Spectacle Independence Questionnaire (PRSIQ)
4. Patient satisfaction questionnaire (VF-14QOL)
|
3 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
30/09/2023 |
| 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="0"
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
|
This study aims to find if Vivity IOL can provide
spherical correction for most working distances in patients with mild irregular
astigmatism, thus, reducing dependency on glasses in such patients without
causing significant visual disturbances.
The study shall evaluate unaided and best corrected visual acuity at
different distances and patient satisfaction in patients with mild irregular
astigmatism. |