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NCT04465344
Multicentric Clinical Study on Isatis TF Trifocal Intraocular Lens
NA trial testing Implantation of trifocal IOL, Isatis TF (device under investigation) in Cataract in 188 participants. Completed in 27 June 2024.
27 June 2024
Quick facts
| Lead sponsor | Cutting Edge SAS |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 188 |
| Start date | 31 May 2021 |
| Primary completion | 27 June 2024 |
| Estimated completion | 27 June 2024 |
| Sites | 7 locations across Spain, Czechia |
Drugs / interventions tested
- Implantation of trifocal IOL, Isatis TF (device under investigation)
- Implantation of monofocal IOL, Isatis (control device)
Conditions studied
- Cataract — all drugs for Cataract →
- Lens Opacities — all drugs for Lens Opacities →
Sponsor
Cutting Edge SAS
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
The study will be a multicentric, prospective open-label ethics committee approved clinical study to investigate safety, visual outcomes, contrast sensitivity and rotational stability after bilateral implantation of Isatis TF IOL following cataract surgery.
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 NCT04465344
- 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.
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- 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 Cutting Edge SAS trials
Trials by the same sponsor.
- NCT06446817 — Bicentric Clinical Investigation to Assess Safety and Performance of LuxHighAdd IOL · NA · recruiting
- NCT06258707 — Bicentric Clinical Investigation to Assess Safety and Performance of LuxBoost IOL · NA · recruiting
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 NCT04465344 (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 Cutting Edge SAS
- Last refreshed: 12 February 2025
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/NCT04465344.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing