Clinical trial NCT05394324: A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
Official title: A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Refractive Error
Glaucoma
Cataracts
Clear Lens Exchange
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-27
Enrollment: 3000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have been implanted with and/or have undergone ophthalmic surgery using commercial JJSV product(s).

Brief summary: Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility criteria: Inclusion Criteria:

1. Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
2. Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months.

Exclusion Criteria:

1. Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
2. Use of surgical devices not in accordance with the product labeling or indications for use
3. Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
4. Use of systemic or ocular medications that may affect vision during the retrospective data collection period
5. Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
6. Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Primary outcomes:
measure: Incidence of Adverse Events
timeFrame: up to 12 months post-operation
measure: BCDVA
timeFrame: up to 12 months post-operation
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Trinity Research Group, LLC
state: Alabama
city: Bakersfield
country: United States
facility: Empire Eye and Laser Center
state: California
city: Bloomington
country: United States
facility: Chu Vision Institute
state: Minnesota
city: McAllen
country: United States
facility: Valley Retina Institute
state: Texas
city: Ahaus
country: Germany
facility: Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH
state: Nordrhein-Westfalen
city: Zschopau
country: Germany
facility: Augenzentrum Erzgebirge
state: SN
city: Berlin
country: Germany
facility: Augentagesklinik Spreebogen Berlin GbR
city: Alicante
country: Spain
facility: Clinica Vistahermosa
state: Alacant
city: Cordoba
country: Spain
facility: Hospital La Arruzafa
state: Andalusia
city: Valladolid
country: Spain
facility: Instituto Universitario de Oftalmobiologia Aplicada
state: CL
city: Barcelona
country: Spain
facility: Hosp. De La Santa Creu I Sant Pau
state: CT
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
state: MD
city: Madrid
country: Spain
facility: Clinica Oftalvist
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson Surgical Vision, Inc. Clinical Trial
role: STUDY_DIRECTOR
References: