Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT06250322




Registration number
NCT06250322
Ethics application status
Date submitted
1/02/2024
Date registered
9/02/2024
Date last updated
28/02/2024

Titles & IDs
Public title
A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
Scientific title
A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
Secondary ID [1] 0 0
PCOL204APME
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cataracts 0 0
Condition category
Condition code
Eye 0 0 0 0
Diseases / disorders of the eye

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Treatment: Devices - Intervention

Treatment: Devices: Intervention
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Visual Symptoms
Timepoint [1] 0 0
3month postoperative
Primary outcome [2] 0 0
Surgeon Experience
Timepoint [2] 0 0
3month postoperative
Primary outcome [3] 0 0
Visual Acuity
Timepoint [3] 0 0
3month postoperative

Eligibility
Key inclusion criteria
- Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days
postoperative from their second eye surgery

- Clear intraocular media

- Signed informed consent and data protection documentation

- 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
Minimum age
No limit
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Subjects with ongoing adverse events that might impact outcomes during the study

- Use of systemic or ocular medication that may affect vision

- Acute or chronic disease or condition, ocular trauma or surgery that may confound
results

- Patients with amblyopia, strabismus, nystagmus

- Concurrent participation in another clinical trial

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
1/03/2024
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
300
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
Country [2] 0 0
France
State/province [2] 0 0
Brest
Country [3] 0 0
France
State/province [3] 0 0
Marseille
Country [4] 0 0
Germany
State/province [4] 0 0
Bochum
Country [5] 0 0
Germany
State/province [5] 0 0
Bonn
Country [6] 0 0
Korea, Republic of
State/province [6] 0 0
Seoul
Country [7] 0 0
Netherlands
State/province [7] 0 0
Breda
Country [8] 0 0
Netherlands
State/province [8] 0 0
Tilburg
Country [9] 0 0
New Zealand
State/province [9] 0 0
Wellington
Country [10] 0 0
Spain
State/province [10] 0 0
Madrid

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Johnson & Johnson Surgical Vision, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon
experience with the TECNIS PC IOL.
Trial website
https://clinicaltrials.gov/ct2/show/NCT06250322
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Johnson & Johnson Surgical Vision, Inc. Clinical Trial
Address 0 0
Johnson & Johnson Surgical Vision, Inc.
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Contact
Address 0 0
Country 0 0
Phone 0 0
+49 170 7804891
Fax 0 0
Email 0 0
mfaust@its.jnj.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT06250322