Observational study on the TECNIS presbyopia-correcting intraocular lens
A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens
This study looks at how well the TECNIS presbyopia-correcting lens works and how satisfied patients are after cataract surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Sex | All |
| Sponsor | Johnson & Johnson Surgical Vision, Inc. Industry-sponsored |
| Locations | 20 sites (Chatswood, New South Wales and 19 other locations) |
| Trial ID | NCT06250322 on ClinicalTrials.gov |
What this trial studies
This observational study collects data on visual symptoms, patient satisfaction, and surgeon experience with the TECNIS presbyopia-correcting intraocular lens (IOL) after patients have undergone cataract surgery. Patients who have been bilaterally implanted with the TECNIS PC IOL will be evaluated at least 45 days post-surgery. The study aims to gather ambispective data to assess the effectiveness and satisfaction associated with this specific lens. The methodology involves patient questionnaires and clinical assessments to understand outcomes better.
Who should consider this trial
Good fit: Ideal candidates are patients who have received bilateral TECNIS PC IOL implants and are at least 45 days postoperative.
Not a fit: Patients with ongoing adverse events affecting their vision or those with specific ocular conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of patient satisfaction and visual outcomes with the TECNIS IOL, potentially leading to improved cataract surgery practices.
How similar studies have performed: Similar observational studies have shown success in evaluating patient outcomes with various intraocular lenses, suggesting this approach is validated.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Chatswood, New South Wales and 19 other locations
- Vision Eye Institute — Chatswood, New South Wales, Australia (Recruiting)
- Sunshine Eye Clinic — Birtinya, Queensland, Australia (Recruiting)
- The Queensland Eye Institute Foundation — Woolloongabba, Queensland, Australia (Not_yet_recruiting)
- Lions Eye Institute — Nedlands, Western Australia, Australia (Recruiting)
- Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute — Vienna, Austria (Completed)
- CHU Morvan Brest — Brest, France (Not_yet_recruiting)
- Clinique Juge Marseille — Marseille, France (Recruiting)
- Augenklinik Ahaus GmbH & Co. KG — Ahaus, Germany (Recruiting)
- Augenklinik Dardenne — Bonn, Germany (Recruiting)
- Narayana Nethralaya — Bangalore 560010, India (Recruiting)
- The Eye Foundation — Coimbatore 641002, India (Recruiting)
- All India Institute of Medical Sciences (AIIMS) — New Delhi 110029, India (Recruiting)
- Centre for Sight Eye Institute — New Delhi, India (Recruiting)
- Kim's eye clinic — Seoul, Korea, Republic of (Not_yet_recruiting)
- Korea Uni.Kuro — Seoul, Korea, Republic of (Withdrawn)
- Oogziekenhuis Rotterdam — Rotterdam, Netherlands (Recruiting)
- Etz — Tilburg, Netherlands (Completed)
- Clinica Oftalmologica Diez del Corral — Madrid, Spain (Completed)
- Mirzana IOA — Madrid, Spain (Not_yet_recruiting)
- Vithas Alicante — Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Study Contact
- Email: mfaust@its.jnj.com
- Phone: +49 170 7804891
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.