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Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

NCT03900260 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2024-02-15

No results posted yet for this study

Summary

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.

Conditions

  • Aphakia

Interventions

DEVICE

Softec HP1 Intraocular Lens

The Softec HP1 IOL is a single-piece, biconvex, ultraviolet absorbing intraocular lens designed for insertion into the posterior chamber of the human eye for visual correction of Aphakia in adults over the age of 21, and as a replacement of a damaged (cataract) natural lens.

Sponsors & Collaborators

  • Lenstec Incorporated

    lead INDUSTRY

Principal Investigators

  • Jean-Pierre Danjoux, MD · Sunderland Eye Infirmary

  • Karen Goodall, MD · Croft Shifa Health Center

  • Mark Benson, MD · Midland Eye Institute

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-25
Primary Completion
2021-07-22
Completion
2021-07-22

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03900260 on ClinicalTrials.gov