Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Clinical Evaluation of the Lenstec Softec HP1 Intraocular Lens

Conditions
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Aphakia

Intervention / Treatment
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* Device: Softec HP1 Intraocular Lens


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 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 Exclusion Criteria: 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 Corneal decompensation History of corneal disease (e.g. herpes simplex, herpes zoster keratitis, etc.) Pseudoexfoliation syndrome Iris atrophy Aniseikonia 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. Participation in another clinical trial within 30 days of study start

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Softec HP1 Intraocular Lens<br>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<br>* 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.<br>|

What is the study measuring?
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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 |