Last reviewed · How we verify
NCT05055076
PMCF Retrospective Study Outcomes of a Monofocal Toric Intraocular Lens
trial testing PODEYE TORIC in Cataract in 105 participants. Completed in 14 December 2021.
14 December 2021
Quick facts
| Lead sponsor | Beaver-Visitec International, Inc. |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 105 |
| Start date | 1 August 2021 |
| Primary completion | 14 December 2021 |
| Estimated completion | 14 December 2021 |
| Sites | 1 location across France |
Drugs / interventions tested
- PODEYE TORIC
Conditions studied
- Cataract — all drugs for Cataract →
- Lens Opacities — all drugs for Lens Opacities →
- Astigmatism — all drugs for Astigmatism →
Sponsor
Beaver-Visitec International, Inc.
Who can join
35 and older, any sex, with Cataract or Lens Opacities. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a monocentric retrospective, open-label clinical study in patients after unilateral or bilateral implantation of hydrophobic acrylic monofocal toric intraocular lens PODEYE TORIC and executed only with standard of care examinations. The investigational device is CE approved. The investigational device and all study products, including the devices used for the study examinations, have been used within the intended use specifications from the manufacturer. In addition, there were no invasive or other burdening examinations. The investigator is an accredited and experienced cataract surgeon and researcher. The primary endpoint is to determine rotational stability in a minimum of 120 eyes of patients with PODEYE TORIC IOL implantation after cataract surgery. Patients will be enrolled for the documentation and evaluation of retrospective data up to 6 months postoperatively.
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 NCT05055076
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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
- NCT05235139 — PMCF Study on Comparison of EDOF Lenses (Switzerland) · 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
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 NCT05055076 (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: 23 August 2022
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/NCT05055076.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing