| CTRI Number |
CTRI/2024/01/061967 [Registered on: 29/01/2024] 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
|
To evaluate clinical outcomes and patient satisfaction with Trifocal Intraocular lens |
|
Scientific Title of Study
|
A Prospective, Single arm, post-marketing clinical study to assess visual
performance and safety of OPTIFLEX TRIO Intraocular lens following bilateral
implantation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| BTVCPL-TRIO-2023-01 Version 1.0 Dated 05/12/2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Mohita Sharma |
| Designation |
Consultant |
| Affiliation |
Tirupati Eye Centre and research Institute |
| Address |
Tirupati Eye Centre and research Institute C 53C Sector33 Near NTPC Township Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971308775 |
| Fax |
|
| Email |
drmohita@tirupatieye.org |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohita Sharma |
| Designation |
Consultant |
| Affiliation |
Tirupati Eye Centre and research Institute |
| Address |
Tirupati Eye Centre and research Institute C 53C Sector33 Near NTPC Township Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971308775 |
| Fax |
|
| Email |
drmohita@tirupatieye.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohita Sharma |
| Designation |
Consultant |
| Affiliation |
Tirupati Eye Centre and research Institute |
| Address |
Tirupati Eye Centre and research Institute C 53C Sector33 Near NTPC Township Noida
Gautam Buddha Nagar
UTTAR PRADESH
201301
India |
| Phone |
9971308775 |
| Fax |
|
| Email |
drmohita@tirupatieye.org |
|
|
Source of Monetary or Material Support
|
| Tirupati eye centre, C-53C, Sector-33 Near NTPC Township
Noida Uttar Pradesh |
|
|
Primary Sponsor
|
| Name |
Tirupati Eye Centre and research Institute |
| Address |
C-53C, Sector-33 Near NTPC Township
Noida |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Mohita Sharma |
Tirupati Eye Centre and research Institute |
4th Floor, clinical research department, C 53C, Sector 33 C, Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9560889495
drmohita@tirupatieye.org |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Independent ethics comittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H259||Unspecified age-related cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
OPTIFLEX TRIO Intraocular lens |
OPTIFLEX TRIO Intraocular Lenses (IOLs) are Trifocal hydrophobic aspheric foldable single piece posterior chamber IOLs. These IOLs are designed to be surgically implanted into the human eye as a replacement for the natural crystalline lens.
The duration of study is 16 months and frequency is as below:
 Pre-operative Visit/Screening Visit
 Surgery Visit/Intra-operative Visit
 Post-operative 1 to 2 Days
 Post-operative 7 Days to 14 Days
 Post-operative 30 Days to 60 Days
 Post-operative 120 Days to 180 Days
 Post-operative 330 Days to 420 Day |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient, 18 years old or older will be enrolled in the study
2. Patient with cataract
3. Calculated IOL power is within the range of the investigational IOL
4. Patients must sign and be given a copy of the written Informed Consent form
5. Clear intraocular media other than cataract
6. Patient willing to undergo the investigations and comply with the follow-up schedule
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 or lactation
4. Concurrent participation in another drug or device investigation
5. Instability of keratometry or biometry measurements
6. Irregular astigmatism
7. More than 1 D of pre-operative corneal astigmatism |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Uncorrected Intermediate Visual Acuity (UIVA) (Photopic)
|
Post-operative: 120-180 days
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Visual Acuity, Subjective Refraction,Intraocular Pressure, Keratometry, Corneal Status, Signs of Inflammation |
[Time Frame: Pre-operative, Postoperative 1-2 days, 7-14 days, 30-60 days, 120-180 days and 330-420 day] |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
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)
|
01/02/2024 |
| 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="1"
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
|
Objective:
To evaluate the visual performance of the Optiflex Trio trifocal intraocular lens in terms of quality of vision and verify the safety profile. The rationale of this study is to obtain safety and efficacy data for the OPTIFLEX TRIO
intraocular lens for cataract patients. Trifocal diffractive lenses were developed to address the
intermediate vision limitations of bifocal IOL designs. To reduce the likelihood of increasing
visual disturbances the designs were such that the dioptric power of the near focal point was
twice the dioptric power of the intermediate focal point. In this way the second harmonic of
the intermediate focal point contributed to the usable light energy at the near point. The
FineVision® (FV) IOL (PhysIOL, Liège, Belgium) is an example of this trifocal design.6,7 The
present study aimed to evaluate visual acuities (distance, intermediate and near), refractive
changes, contrast sensitivity, defocus curve, and postoperative satisfaction of a new diffractive
trifocal IOL (Optiflex TRIO). |