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NCT05235139: PHY2130
PMCF Study on Comparison of EDOF Lenses (Switzerland)
NA trial testing IOL implantation experimental (ISOPURE 1.2.3.) in Cataract in 73 participants. Completed in 22 August 2023.
22 August 2023
Quick facts
| Lead sponsor | Beaver-Visitec International, Inc. |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 73 |
| Start date | 9 March 2022 |
| Primary completion | 22 August 2023 |
| Estimated completion | 22 August 2023 |
| Sites | 1 location across Switzerland |
Drugs / interventions tested
- IOL implantation experimental (ISOPURE 1.2.3.)
- IOL implantation active comparator (Acrysof Vivity)
Conditions studied
- Cataract — all drugs for Cataract →
- Lens Opacities — all drugs for Lens Opacities →
Sponsor
Beaver-Visitec International, Inc.
Who can join
50 and older, any sex, with Cataract or Lens Opacities. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Single center, prospective, randomised, controlled, double-blind post-market clinical follow-up (PMCF) study to compare the clinical outcomes of a premium monofocal intraocular lens (PhysIOL ISOPURE 1.2.3.) with clinical data obtained in a control group implanted with an EDOF IOL (Alcon Acrysof IQ Vivity).
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT05235139
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of IOL implantation experimental (ISOPURE 1.2.3.)
Trials testing the same drug.
- NCT05875922 — Comparison of ISOPURE and EYHANCE (Switzerland) · NA · completed
Other recruiting trials for Cataract
Currently open trials in the same condition.
- NCT07301385 — Evaluation of Head-Mounted Spatial Computing and Three-Dimensional (3D) Visualization in Ocular Microsurgery: A Safety a · NA · recruiting
- NCT07462000 — Aqueous Humor and Ocular Tissue Analysis in Glaucoma and Cataract · NA · recruiting
- NCT06891092 — Vivinex Impress XY1-EM vs RayOne EMV · NA · recruiting
- NCT07218796 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
- NCT07218783 — Evaluation of the Safety and Efficacy of the Bimatoprost Implant System Used in Combination With the SpyGlass IOL Compar · Phase 3 · recruiting
Other Beaver-Visitec International, Inc. trials
Trials by the same sponsor.
- NCT05875922 — Comparison of ISOPURE and EYHANCE (Switzerland) · NA · completed
- NCT04176965 — Investigation of the Safety and Effectiveness of a Trifocal IOL · NA · completed
- NCT05255029 — Clinical Investigation of a Monofocal Toric Intra Ocular Lens (IOL) in Cataractous Eyes · NA · completed
- NCT04987216 — PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Europe (PHY2104) · NA · completed
- NCT04778501 — PMCF Study on Monofocal Toric IOL (PODEYE TORIC) in Asia · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05235139 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Beaver-Visitec International, Inc.
- Last refreshed: 9 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05235139.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing