Clinical trial NCT06250322: A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
Official title: A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2024-02-09
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A pre-existing population of subjects bilaterally implanted with the PC IOL at approximately 20 sites in Europe and Asia Pacific. Bilateral pseudophakic subjects implanted with the TECNIS PC IOL will be enrolled.

Brief summary: Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.


Eligibility criteria: 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

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

Primary outcomes:
measure: Visual Symptoms
timeFrame: 3month postoperative
measure: Surgeon Experience
timeFrame: 3month postoperative
measure: Visual Acuity
timeFrame: 3month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Chatswood
country: Australia
facility: Vision Eye Institute
state: New South Wales
city: Birtinya
country: Australia
facility: Sunshine Eye Clinic
state: Queensland
city: Woolloongabba
country: Australia
facility: The Queensland Eye Institute Foundation
state: Queensland
city: Nedlands
country: Australia
facility: Lions Eye Institute
state: Western Australia
city: Vienna
country: Austria
facility: Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute
city: Brest
country: France
facility: CHU Morvan Brest
city: Marseille
country: France
facility: Clinique Juge Marseille
city: Ahaus
country: Germany
facility: Augenklinik Ahaus GmbH & Co. KG
city: Bonn
country: Germany
facility: Augenklinik Dardenne
city: Bangalore 560010
country: India
facility: Narayana Nethralaya
city: Coimbatore 641002
country: India
facility: The Eye Foundation
city: New Delhi 110029
country: India
facility: All India Institute of Medical Sciences (AIIMS)
city: New Delhi
country: India
facility: Centre for Sight Eye Institute
city: Seoul
country: Korea, Republic of
facility: Kim's eye clinic
city: Seoul
country: Korea, Republic of
facility: Korea Uni.Kuro
city: Rotterdam
country: Netherlands
facility: Oogziekenhuis Rotterdam
city: Tilburg
country: Netherlands
facility: ETZ
city: Madrid
country: Spain
facility: Clinica Oftalmologica Diez del Corral
city: Madrid
country: Spain
facility: Mirzana IOA
city: Madrid
country: Spain
facility: Vithas Alicante
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: