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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05394324
Other study ID # JJSV301PMCF
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date June 21, 2022
Est. completion date May 31, 2025

Study information

Verified date June 2024
Source Johnson & Johnson Surgical Vision, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 3000
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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.

Study Design


Intervention

Device:
Intervention
No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with subject devices of this study.

Locations

Country Name City State
Germany Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH Ahaus Nordrhein-Westfalen
Germany Augentagesklinik Spreebogen Berlin GbR Berlin
Germany Augenzentrum Erzgebirge Zschopau SN
Spain Clinica Vistahermosa Alicante Alacant
Spain Hosp. De La Santa Creu I Sant Pau Barcelona CT
Spain Hospital La Arruzafa Cordoba Andalusia
Spain Clinica Oftalvist Madrid
Spain Hospital Clinico San Carlos Madrid MD
Spain Instituto Universitario de Oftalmobiologia Aplicada Valladolid CL
United States Empire Eye and Laser Center Bakersfield California
United States Chu Vision Institute Bloomington Minnesota
United States Trinity Research Group, LLC Dothan Alabama
United States Valley Retina Institute McAllen Texas

Sponsors (1)

Lead Sponsor Collaborator
Johnson & Johnson Surgical Vision, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of Adverse Events incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints. up to 12 months post-operation
Primary BCDVA The proportion of eyes achieving 20/40 or better BCDVA. up to 12 months post-operation
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