Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Aphakia
• Intervention / Treatment: Device: Softec HP1 Intraocular Lens

Detailed Description

Recruitment will be performed by the 3 Clinical Investigators (Jean-Pierre Danjoux - Sunderland Eye Infirmary, Karen Goodall - Croft Shifa Health Center, Mark Benson - Midland Eye Institute) and any appropriate, pre-trained staff within the hospital using the inclusion and exclusion criteria set out in the protocol. Patient selection will involve anyone over the age of 21 with an age-related cataract regardless of ethnicity, religion or gender.

An Informed Consent Form (ICF) will be explained with patients in full which will be signed by both the Principal Investigator (PI) and the patient with full understanding. Understanding fully means that the patient understands the nature of the operation, the benefits to the operation and also any risks or burdens.

The consent form also states alternatives to participation in the trial other than the option being put forward. The patients will be of sound enough mind to retain the information from the ICF and will be given time to digest this in order to make a free and effective decision to join the study.

All risks and benefits are explained in the ICF and are no more or less than that of a standard cataract surgery provided on a daily basis by NHS consultants. All surgeries will be performed by the PI.

Confidentiality shall be kept at all times with the PI and clinical staff using a unique patient reference number that in no instance indicates the identity of the patient to the study sponsor (Lenstec Inc.) or anyone else outside of the hospital. Any other confidentiality issues will run in conjunction with the hospital policy of which the staff involved in the study are aware.

There are no tissue samples to be used in this study.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Walcott; Phone Number: 2464206795; Email: jwalcott@lenstec.com
• Study Contact Backup: Name: Ian Hickling; Phone Number: 2464206795; Email: ihickling@lenstec.com

Study Locations

• United Kingdom
  • Rochdale, United Kingdom, OL16 2UP
    • Croft Shifa health Centre
  • Solihull, United Kingdom, B91 2AW
    • Midland Eye Institute
  • Sunderland, United Kingdom, SR2 9HP
    • Sunderland Eye Infirmary

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

1. ≥ 21 years of age, of any race and either gender
2. Operable, age related cataract grade in one or both eyes
3. Patients who require an IOL power in the range of 10.0 - 30.0 D only
4. Able to comprehend and sign a statement of informed consent
5. Planned cataract removal by phacoemulsification
6. Potential postoperative visual acuity of 0.2 logMAR or better
7. No other ocular or systemic pathology that may affect visual outcome following cataract surgery
8. Clear intraocular media other than cataract in study eyes
9. Preoperative Best Corrected Visual Acuity (BCVA - VA taken with original manifest refraction) worse than 0.2 logMAR
10. Able to competently complete testing
11. Willing and able to attend study visits

Exclusion Criteria:

1. Previous intraocular surgery
2. Previous corneal refractive surgery
3. Any inflammation or oedema (swelling) of the cornea
4. Pterygium with corneal involvement or has the potential of corneal involvement (in the opinion of the Investigator)
5. Amblyopia
6. Clinically significant ptosis
7. Clinically severe corneal dystrophy (e.g. epithelial, stromal, or endothelial dystrophy), keratitis, keratoconjunctivitis, keratouveitis, keratopathy, or kerectasia
8. Diabetic Retinopathy
9. Previous retinal detachment
10. Previous corneal transplant
11. Iris neovascularization
12. Glaucoma (medically controlled or uncontrolled)
13. Aniridia
14. Chronic severe uveitis
15. Optic nerve atrophy
16. Corneal decompensation
17. History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.)
18. Pseudoexfoliation syndrome
19. Iris atrophy
20. Aniseikonia
21. Pregnant, lactating, or planning to become pregnant during the course of the trial Note: Patients who become pregnant during the study will not be discontinued; however, data may be excluded from the effectiveness analyses because pregnancy can alter refraction and visual acuity results.
22. Participation in another clinical trial within 30 days of study start

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Uncorrected Distance Visual Acuity (UCDVA)	The postoperative UCDVA 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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication Rates	Up to 75 patients will be evaluated for intraoperative and postoperative complications, and these will be compared to the complication rates provided in the FDA Grid.	3 months

Collaborators and Investigators

• Sponsor: Lenstec Incorporated
• Investigators: Principal Investigator: Jean-Pierre Danjoux, MD, Sunderland Eye Infirmary; Principal Investigator: Karen Goodall, MD, Croft Shifa Health Center; Principal Investigator: Mark Benson, MD, Midland Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2019
• Primary Completion (Actual): July 22, 2021
• Study Completion (Actual): July 22, 2021

Study Registration Dates

• First Submitted: April 1, 2019
• First Submitted That Met QC Criteria: April 1, 2019
• First Posted (Actual): April 3, 2019

Study Record Updates

• Last Update Posted (Actual): February 15, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Aphakia
• Other Study ID Numbers: PR505

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No