| CTRI Number |
CTRI/2024/05/068178 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To evaluate the visual outcome of a new multifocal intraocular lens. |
|
Scientific Title of Study
|
Assessment of visual performance of a new panfocal intraocular lens for visual quality and safety (Naturo, Caregroup, SS Pvt. Ltd.) |
| 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 Namrata Sharma |
| Designation |
Professor |
| Affiliation |
Dr R P Centre for Ophthalmic Sciences |
| Address |
Room no. 494, 4th floor, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi
Central
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
Namrata.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor |
| Affiliation |
Dr R P Centre for Ophthalmic Sciences |
| Address |
Room no. 494, 4th floor, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi
Central
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
Namrata.sharma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor |
| Affiliation |
Dr R P Centre for Ophthalmic Sciences |
| Address |
Room no. 494, 4th floor, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar New Delhi
Central
DELHI
110029
India |
| Phone |
9810856988 |
| Fax |
|
| Email |
Namrata.sharma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Care group SS Pvt Ltd, Block no. 310, Village Sim of Dabhasa Taluka-Padra Vadodara,-391440 |
|
|
Primary Sponsor
|
| Name |
Caregroup, SS Pvt Ltd |
| Address |
Block no. 310, Village Sim of Dabhasa Taluka- Padra Vadodara- 391440, India |
| Type of Sponsor |
Other [INTRAOCULAR IMPLANT MANUFACTURER] |
|
|
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 Namrata Sharma |
Dr. Rajendra Prasad Centre for ophthalmic sciences |
Room no. 495, 4th Floor Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, Ansari Nagar, New Delhi 110029
South
DELHI |
9810856988
namrata.sharma@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE AIIMS NEW DELHI 110029 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H251||Age-related nuclear cataract, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient with bilateral age related senile cataract
2. grade of cataract permitting optical biometry
3. no ocular/systemic contraindication for surgery
4. a patient with preoperative corneal astigmatism less than 1D in each eye
5. normal macular functions with normal anantomy of macula as seen on optical coherence tomography
6. no history or evidence of ocular anatomical or functional disorders other than cataract including strabismus neuro-ophthalmological disorders of optic nerve or high visual functions corneal pathologies disorders of uvea vitreous pathologies retinal disorders
7. no systemic contraindications to surgery under local anaesthesia
8. patient willing to undergo the investigations and comply with the follow-up schedule |
|
| ExclusionCriteria |
| Details |
1. cataract precluding optical biometry
2. posterier-segment pathology
3. media opacity other than cataract
4. corneal higher order aberrations more than 0.3 micron as measured on ray-tracing wavefront aberrometer
5. patients with potential for intraoperative complications such as floppy iris syndrome and pseudo-exfoliation syndrome
6. cases where intra-operative complications compromise IOL placement with proper centration in the capsule bag
7. patient unwilling to undergo the required investigations or follow-up |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. visual acuity
uncorrected & best corrected distance intermediate & near visual acuity
2. quality of vision |
1. Pre-operative visit
2. Operative visit
3. Post-operative visit 1 - Day 1
4. Post-operative visit 2 - 1 month
3. Post-operative visit 3 - 3 months
3. Post-operative visit 4 - 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
12/07/2024 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Clinical Study Report
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [namrata.sharma@gmail.com].
- For how long will this data be available start date provided 01-08-2024 and end date provided 21-07-2023?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
|
Brief Summary
|
this study is being conducted to evaluate the visual performance of a trifocal intraocular lens which has become recently available in India for correction of presbyopia after cataract extraction. The study is a post marketing clinical surveillance |