Clinical Comparison of a Monofocal eDOF IOL With a Monofocal IOL

Study Overview
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Brief Summary
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Post-market, prospective, randomized, single-masked, multi-center clinical study investigating the safety and effectiveness of the Monofocal Extended Depth of Focus Intraocular Lens (Mono-EDoF IOL) when compared to a Standard Monofocal Intraocular Lens. Primary Objectives: To evaluate the distance VA of the study IOLs To evaluate the intermediate VA of the study IOLs To explore the safety profile with regards to visual disturbances

Detailed Description
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This study is aimed at patients who have a cloudy lens in both of their eyes, and are eligible for cataract surgery with implantation of an intraocular lens. Patients should be otherwise healthy with no other eye diseases. The study will take place in 3 centers in Europe, including Oxford Eye Hospital, a part of Oxford University Hospitals NHS Trust and will include 70 patients in total. The aim of the study is to investigate the safety and effectiveness of a new Intraocular Lens (IOL): the Monofocal Extended Depth of Focus (Mono-EDoF ME4) IOL and to compare it to a standard Monofocal IOL (TECNIS ZBC00). Patients participating will be randomised to either receive the Mono-EDoF ME4 IOL in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL. Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses. Total duration of clinical investigation is 12 months and the total expected duration for each patient is 8 months. Patients will be screened for eligibility preoperatively obtaining a medical history and to establish a baseline ocular condition. Surgeries will be performed on different dates for both eyes but not more than one month apart. The patient will need to return to for seven follow-up visits after eye surgery where vision and health of the eye will be assessed.

Official Title
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A Prospective, Randomized, Multicentric Clinical Evaluation Comparing a Monofocal Extended Depth of Focus IOL With a Monofocal IOL

Conditions
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Cataract

Intervention / Treatment
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* Procedure: Cataract surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults 22 years of age and older at the time of consent. Cataracts in both eyes. Expected post-operative refractive astigmatism of ≤ 1.0 D. Calculated lens power from 18 D to 30 D for both study IOLs. Willing and able to return for all scheduled treatment and post-operative visits for a minimum of 6 months. Planned removal of visually significant cataract (cortical, nuclear, posterior subcapsular, or a combination) by phacoemulsification cataract extraction in both eyes. Willing to discontinue contact lens wear, if applicable, and demonstrate corneal stability prior to biometry and surgery. Preoperative best corrected distance visual acuity (BCDVA) of 20/32 or worse, with or without a glare source, or preoperative BCDVA of 20/25 or worse with patient complaining of severe visual disturbances attributable to cataract. Post-operative BCVA projected to be 0.2 LogMAR or better (as determined by the medical judgment of the Investigator or measured by potential acuity meter / retinal acuity meter (PAM / RAM) if necessary). Pharmacologically dilated pupil size at least 6.0 mm. Must be able to understand and provide informed consent themselves or through a representative with a witness present on the IRB or EC approved Informed Consent Form (ICF). Exclusion Criteria: Participation in any other drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation. Pregnancy or lactation. Subject who, in the clinical judgment of the Investigator, is not suitable for participation in the study for another clinical reason, as documented by the investigator (reason to be documented by the site on Case Report Forms - CRF's). Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria. History of any intraocular or corneal surgery in either eye (including LASIK, PRK, etc.). Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in either eye. Any anterior segment pathology likely to increase the risk of complications from phacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis, aniridia, rubeosis iridis, clinically significant corneal disease, Fuchs, or anterior membrane dystrophies, etc.) in either eye. Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation. Any visually significant intraocular media opacity other than cataract in either eye. History of any clinically significant retinal pathology or ocular diagnosis (e.g., diabetic retinopathy, ischemic disease, macular degeneration, retinal detachment, amblyopia, optic neuropathy, microphthalmos, aniridia, etc.) in either eye that could alter or limit final postoperative visual prognosis. History of cystoid macular edema in either eye. Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements. Uncontrolled (e.g., non-medicated) glaucoma in either eye. Extremely shallow anterior chamber (< 2.0 mm). Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes. Irregular astigmatism, corneal degeneration or dystrophy. Uncontrolled systemic disease (e.g., diabetes mellitus, active cancer treatment, mental illness, etc.) in the opinion of the Investigator, would put the subject's health at risk and/or prevent the subject from completing all study visits. Systemic medication that, in the opinion of the investigator, may confound the outcome or increase the intraoperative and post-operative risk to the subject (e.g., Tamsulosin Hydrochloride) or other medications including anticholinergics, alpha adrenergic blocking agents with similar side effects (e.g., small pupil/floppy iris syndrome). Subjects who may reasonably be expected to require any additional ophthalmic surgical intervention at any time during the study (other than YAG capsulotomy). Need for concomitant procedures (e.g., glaucoma surgery, RK, LASIK, etc.).

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Patients participating will be randomised to either receive the Mono-EDoF ME4 Intraocular Lens (IOL) in both eyes or the TECNIS ZCB00 IOL in both eyes. Twice as many subjects will receive the Mono-EDoF ME4 IOL compared to the TECNIS ZCB00 IOL. Both IOLs have received the CE marked. The aim with both IOLs is to provide patients good vision at distance with no glasses. The Mono-eDoF ME4 might offer the additional benefit of achieving good vision at intermediate distance without glasses.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Santen xact Mono-EDoF ME4 Intraocular Lens (IOL)<br>The Monofocal Extended Depth of Focus (Mono-EDoF) posterior chamber foldable intraocular lens is ultraviolet and blue-light absorbing designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. The diffractive technology of the IOL allows most of the light to converge in one focal point thereby providing high quality of distance vision and continuous focus to intermediate vision while minimizing the effects of unwanted visual disturbances. The visual quality is expected to be similar to monofocal IOLs. Surgery to implant the Mono-EDoF ME4 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification. | Procedure: Cataract surgery<br>* Small incision cataract surgery with implantation of an intraocular lens<br>|
| Placebo Comparator: J&J TECNIS ZCB00 Intraocular Lens (IOL)<br>The TECNIS 1-Piece Intraocular Lens (IOL), Model ZCB00, is a standard monofocal ultraviolet light absorbing posterior chamber IOL, which is designed to be positioned in the lens capsule to replace the optical function of the natural crystalline lens. Surgery to implant the TECNIS ZCB00 Intraocular Lens (IOL) will be performed on Day 0 of the study, using standard microsurgical techniques. All instruments and procedures used will be identical to those routinely used for small incision phacoemulsification. | Procedure: Cataract surgery<br>* Small incision cataract surgery with implantation of an intraocular lens<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Uncorrected Distance VA at Visit 4 (Month 3) | Monocular uncorrected distance visual acuity measured using ETDRS visual acuity chart | 80-100 days after second eye surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Monocular Distance Corrected Intermediate VA at Visit 4 (Month 3) | Subject's vision is corrected for distance and then subject's intermediate vision is measured using a 66-cm ETDRS chart. | 80-100 days after second eye surgery | 
| Monocular Uncorrected Intermediate VA at Visit 4 (Month 3) | Intermediate Visual Acuity is measured using a 66-cm ETDRS chart. | 80-100 days after second eye surgery |