| CTRI Number |
CTRI/2025/04/083898 [Registered on: 02/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
PMS |
|
Type of Study
|
Medical Device |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL. |
|
Scientific Title of Study
|
MULTICENTER, OBSERVATIONAL, SINGLE ARM STUDY OF THE
TECNIS PRESBYOPIA-CORRECTING INTRAOCULAR LENS |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NCT06250322 |
ClinicalTrials.gov |
| PCOL204APME, Version 3.0, Nov 2023 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Namrata Sharma |
| Designation |
Professor of Ophthalmology. In-charge, Unit-IV, Cornea, Cataract and Refractive Surgery Services |
| Affiliation |
All India Institute of Medical Sciences (AIIMS) |
| Address |
Room Number 494- 495,Department of Ophthalmology, Unit-IV, Cornea, Cataract and Refractive Surgery Services, Dr R P Centre for Ophthalmic Sciences, AIIMS , New Delhi 110029 , India
New Delhi
DELHI
110029
India |
| Phone |
0911126593144 |
| Fax |
|
| Email |
namrata.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Michael Faust |
| Designation |
Associate Director Clinical Operations |
| Affiliation |
Johnson & Johnson Surgical Vision, Inc. |
| Address |
Johnson and Johnson Surgical Vision India Private Limited
Level 12, Two Horizon Center, Golf Course Road,
DLF Phase V, Sec 43
Gurgaon, Haryana
Gurgaon
HARYANA
122002
India |
| Phone |
0491707804891 |
| Fax |
|
| Email |
mfaust@its.jnj.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akshay Shah |
| Designation |
Site Manager |
| Affiliation |
Johnson & Johnson Surgical Vision, Inc. |
| Address |
Johnson and Johnson Surgical Vision India Private Limited
Level 12, Two Horizon Center, Golf Course Road,
DLF Phase V, Sec 43
Gurgaon, Haryana
Gurgaon
HARYANA
122002
India |
| Phone |
9879144653 |
| Fax |
|
| Email |
ashah2@its.jnj.com |
|
|
Source of Monetary or Material Support
|
| Johnson & Johnson Surgical Vision, Inc. |
|
|
Primary Sponsor
|
| Name |
Johnson & Johnson Surgical Vision, Inc. |
| Address |
31 Technology Drive, Suite 200, Irvine, CA 92618, USA
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
Austria
France
Germany
India
Netherlands
Spain |
|
Sites of Study
|
| No of Sites = 4 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Namrata Sharma |
All India Institute of Medical Sciences |
Room Number 494- 495,Department of Ophthalmology, Unit-IV, Cornea, Cataract and Refractive Surgery Services, Dr R P Centre for Ophthalmic Sciences, AIIMS , New Delhi 110029 , India
New Delhi
DELHI |
01126593144
namrata.sharma@gmail.com |
| Dr Mahipal Sachdev |
Centre for Sight Eye Institute |
Department of Refractive Surgery, B-5/24 Safdarjung Enclave, New Delhi, India 110029
New Delhi
DELHI |
01142504250
drmahipal@gmail.com |
| Dr Naren Shetty |
Narayana Nethralaya |
Department of Cataract and Refractive Lens Services, #121/C Chord Road, 1st ‘R Block, Rajaji Nagar, Bangalore 560010, India
Bangalore
KARNATAKA |
08066121643
narenshetty.27@gmail.com |
| Dr D Ramamurthy |
The Eye Foundation |
Department of Cataract, Ophthalmology (Eye), Refractive Surgery / Lasik, 582A, D B Road, R S Puram, Coimbatore - 641002, India
Coimbatore
TAMIL NADU |
04224242000
drramamurthy@theeyefoundation.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Centre for Sight Institutional Ethics Committee |
Approved |
| Institute Ethics Committee -All India Institute of Medical Sciences (AIIMS) |
Approved |
| Narayana Nethralaya Ethics Committee |
Approved |
| The Eye Foundation |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H524||Presbyopia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Intraocular lens-- TECNIS PureSee IOL |
No study treatments will be administered during this study. However, data will be collected from medical records of patients who have been treated with the subject device of this study. |
| Comparator Agent |
Not Applicable for single arm study |
Not Applicable for single arm study |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients who are bilaterally implanted with TECNIS PureSee IOL following cataract extraction and are at least 45 days postoperative from their second eye surgery at the time of the study visit:
- Eyes may be implanted with any combination of TECNIS PureSee non-toric (Model DEN00V) and/or Toric II IOL (Models DET100, DET150, DET225, DET300, DET375, DET450, DET525 and DET600);
- Patients with or without prior corneal refractive surgery;
- Clear intraocular media;
- Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to study procedures in the governing countries;
- Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;
• Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
|
|
| ExclusionCriteria |
| Details |
1. Subjects with ongoing adverse events and/or surgical complications that might impact outcomes during the study visit as determined
by the investigator;
2. Use of systemic or ocular medication that may affect vision;
3. Acute or chronic disease or condition, ocular trauma or surgery that may confound results (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus etc.);
4. Patients with amblyopia, strabismus, nystagmus;
5. Concurrent participation in another clinical trial.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Patient questionnaires for visual symptoms and satisfaction
2. Surgeon experience questionnaire
3. Monocular and binocular best-corrected distance visual acuity (BCDVA)
4. Monocular and binocular uncorrected distance visual acuity (UCDVA)
5. Manifest refraction
6. Binocular uncorrected and distance-corrected intermediate visual acuity (UCIVA & DCIVA) at 66 cm
|
3 months Postoperative after surgery of the 2nd eye |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Visual Symptoms
2. Surgeon Experience
3. Visual Acuity |
3 months Postoperative after surgery of the 2nd eye |
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="80" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
15/04/2025 |
| Date of Study Completion (India) |
13/11/2025 |
| Date of First Enrollment (Global) |
01/08/2024 |
| Date of Study Completion (Global) |
13/11/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
The intraocular lenses (IOL) tested in this study, TECNIS PureSee non-toric (model DEN00V) and/or Toric II IOL (models DET100, DET150, DET225, DET300, DET375, DET450, DET525 and DET600), are an EDOF IOL with extended depth of focus that provides good distance vision as well as improved intermediate and near vision compared to a standard monofocal IOL. The study is an observational study of patients’ and surgeons’ experiences with the TECNIS PureSeeâ„¢ IOL. The lack of a control arm is justified as it is a non-comparative evaluation of a CE-marked product with a focus on collecting data on surgeons’ and patients’ experiences with the product. Post-market data on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PureSeeTM IOL will be collected within the clinical observational study. Multicenter, single-arm, bilateral clinical observational study. A total of approximately 300 patients will be included, who will be called in once for a prospective postoperative follow-up examination 3 months after bilateral implantation. The preoperative and operative data will be collected retrospectively after inclusion of the patients. Measures and procedure: After informed consent of the patient and examination of the inclusion and exclusion criteria, each patient will be called in once for a prospective postoperative follow-up examination 3 months (45 -90 days) after surgery of the 2nd eye. During this postoperative visit, visual acuity is measured at distance, intermediate and near. Data on visual symptoms and patient satisfaction are collected. In addition, the binocular measurement of the defocus curve is carried out if necessary. The preliminary examination and the operations on both eyes are not part of the study. The data routinely collected by each study center will be collected retrospectively from the patient’s file after the patient’s consent, and after the single postoperative follow-up examination has been performed for all patients per study center, the surgeons involved per study center will be asked to complete a questionnaire on their experiences with the IOL. The study will be conducted in EMAE and APAC. 10 EMEA site are included in Germany (2), Netherlands (2), Spain (3), Austria (1), France (2). The study was already approved in all countries included. 4 Sites have been activated, 3 site have started recruitment. 10 APAC sites are planned: Australia (4), Korea (2), India (4)
|