NCT03900260

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
87

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2019

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 3, 2019

Completed
22 days until next milestone

Study Start

First participant enrolled

April 25, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 22, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 22, 2021

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2.2 years

First QC Date

April 1, 2019

Last Update Submit

February 13, 2024

Conditions

Aphakia

Outcome Measures

Primary Outcomes (1)

  • Best Corrected Distance Visual Acuity (BCDVA)

    The postoperative BCDVA for up to 75 patients will be measured under normal lighting conditions using a phoropter or trial frames, and these results will be evaluated by the sponsor on completion of the study.

    3 months

Secondary Outcomes (1)

  • Uncorrected Distance Visual Acuity (UCDVA)

    3 months

Other Outcomes (1)

  • Complication Rates

    3 months

Study Arms (1)

Softec HP1 Intraocular Lens

OTHER

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.

Device: Softec HP1 Intraocular Lens

Interventions

Softec HP1 Intraocular LensDEVICE

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.

Softec HP1 Intraocular Lens

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • ≥ 21 years of age, of any race and either gender
  • Operable, age related cataract grade in one or both eyes
  • Patients who require an IOL power in the range of 10.0 - 30.0 D only
  • Able to comprehend and sign a statement of informed consent
  • Planned cataract removal by phacoemulsification
  • Potential postoperative visual acuity of 0.2 logMAR or better
  • No other ocular or systemic pathology that may affect visual outcome following cataract surgery
  • Clear intraocular media other than cataract in study eyes
  • Preoperative Best Corrected Visual Acuity (BCVA - VA taken with original manifest refraction) worse than 0.2 logMAR
  • Able to competently complete testing
  • Willing and able to attend study visits

You may not qualify if:

  • Previous intraocular surgery
  • Previous corneal refractive surgery
  • Any inflammation or oedema (swelling) of the cornea
  • Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)
  • Amblyopia
  • Clinically significant ptosis
  • Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
  • Diabetic Retinopathy
  • Previous retinal detachment
  • Previous corneal transplant
  • Iris neovascularization
  • Glaucoma (medically controlled or uncontrolled)
  • Aniridia
  • Chronic severe uveitis
  • Optic nerve atrophy
  • +7 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Croft Shifa health Centre

Rochdale, OL16 2UP, United Kingdom

Location

Midland Eye Institute

Solihull, B91 2AW, United Kingdom

Location

Sunderland Eye Infirmary

Sunderland, SR2 9HP, United Kingdom

Location

MeSH Terms

Conditions

Aphakia

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Jean-Pierre Danjoux, MD

    Sunderland Eye Infirmary

    PRINCIPAL INVESTIGATOR

  • Karen Goodall, MD

    Croft Shifa Health Center

    PRINCIPAL INVESTIGATOR

  • Mark Benson, MD

    Midland Eye Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2019

First Posted

April 3, 2019

Study Start

April 25, 2019

Primary Completion

July 22, 2021

Study Completion

July 22, 2021

Last Updated

February 15, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

GB(3)