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NCT03900260
Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens
NA trial testing Softec HP1 Intraocular Lens in Aphakia in 87 participants. Completed in 22 July 2021.
22 July 2021
Quick facts
| Lead sponsor | Lenstec Incorporated |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | other |
| Enrollment | 87 |
| Start date | 25 April 2019 |
| Primary completion | 22 July 2021 |
| Estimated completion | 22 July 2021 |
| Sites | 3 locations across United Kingdom |
Drugs / interventions tested
- Softec HP1 Intraocular Lens
Conditions studied
- Aphakia — all drugs for Aphakia →
Sponsor
Lenstec Incorporated
Who can join
21 and older, any sex, with Aphakia. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The study is designed as a post market evaluation of the Softec HP1 IOL for continuance of the CE certificate. The primary effectiveness endpoint is to evaluate the safety and performance levels produced by this IOL in patients requiring standard cataract surgery. There will be no change from standard procedure, other than 1 extra post op evaluation.
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 NCT03900260
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Aphakia
Currently open trials in the same condition.
- 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 NCT03900260 (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 Lenstec Incorporated
- Last refreshed: 15 February 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/NCT03900260.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing