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NCT03900260

Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Completed NA Last updated 15 February 2024
What this trial tests

NA trial testing Softec HP1 Intraocular Lens in Aphakia in 87 participants. Completed in 22 July 2021.

Timeline
25 April 2019
Primary endpoint
22 July 2021
22 July 2021

Quick facts

Lead sponsorLenstec Incorporated
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposeother
Enrollment87
Start date25 April 2019
Primary completion22 July 2021
Estimated completion22 July 2021
Sites3 locations across United Kingdom

Drugs / interventions tested

Conditions studied

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.

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Other recruiting trials for Aphakia

Currently open trials in the same condition.

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Data sources for this page

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