Evaluation of Safety and Performance Outcomes of Eyedeal IOL Implantation After Cataract Removal

Study Overview
=================
Brief Summary
-----------------
A cataract is the clouding of the natural lens in the eye and is very common as when getting older. A cloudy lens makes it difficult to see. A cataract is treated by removing the cloudy lens and replacing it with an intraocular lens (known as an IOL). The goal of this clinical trial is to determine if the Eyedeal® IOL can be safely implanted in a subject's eye and if it can replace efficiently the natural lens. Subjects will be asked to attend a total of seven visits for this study for a period of 12 months after surgery.

Detailed Description
-----------------
To investigate the safety and performance of the Eyedeal® PX65AS1 intraocular lens (IOL) To evaluate the safety profile with regards to best-corrected visual acuity, and adverse events To evaluate the performance with regards of best corrected distance VA after the device implantation The Eyedeal® IOL (model PX65AS1) is a clear foldable single-piece ultra-violet absorbing posterior chamber monofocal IOL. It is an optical implant for the replacement of the human crystalline lens in the visual correction of aphakia in adult patients after cataract surgery. The Eyedeal® IOL is made of a high refractive index soft hydrophobic crosslinked polyisobutylene material. It is composed of an equi-convex all-optical surface and double C-loop haptics. The front and rear optical surfaces are equi-convex aspheric surfaces with no spherical aberration. The haptics ensure that the lens centration and fixation. IOL powers vary from +0.5D to 30D with 0.5D increment and from +30D to +34D with 1.0D increment. The optical diameter is 6.5 mm and the overall length is 13.0 mm.

Official Title
-----------------
A Prospective, Multicenter Study to Evaluate Safety and Performance Outcomes of Eyedeal Intraocular Lens Implantation After Cataract Removal

Conditions
-----------------
Lens Implantation, Intraocular

Intervention / Treatment
-----------------
* Procedure: Cataract surgery
* Device: Eyedeal® Model PX65AS1 IOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (22 years of age or older at the time of surgery) of any gender and race, diagnosed with age related cataracts in one eye. Preoperative best corrected distance visual acuity (BCDVA) of 20/32 or worse. Projected postoperative BCDVA 0.20 logMAR or better in the study eye, as determined by Investigator's medical judgment. Calculated spherical power targeted at emmetropia at distance in the study eye. Calculated lens power within the available range for the Eyedeal® Model PX65AS1 IOL (+0.50D - +34.00D). Planned cataract removal by phacoemulsification procedure. Clear intraocular media other than cataract, in the study eye. Pharmacologically dilated pupil size of at least 6.0mm. 2.0 D or less of preoperative astigmatism in the study eye. Willing and able to complete all required postoperative visits. Able to comprehend and sign or through a representative, with a witness present, a statement of IRB or EC approved Informed Consent Form (ICF). Exclusion Criteria: Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria. Ocular conditions which could affect the stability of the IOL (e.g., pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) in the study 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 disorders, (Fuch's, or anterior basement membrane dystrophy, etc.) in the study 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 the study 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, neuro-ophthalmic disease, fixation problems etc.) in the study eye that could alter or limit final postoperative visual prognosis. History of any intraocular, retinal, corneal or refractive surgery in the study eye (including LASIK, PRK, LRI, etc.). History of cystoid macular edema in the study eye. History of serious corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) in either eye. Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements. Uncontrolled glaucoma and/or optic atrophy in the study eye. Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism). 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, LRI, RK, LASIK, etc.). Fellow eye BCDVA worse than 1.0 logMAR. Extremely shallow anterior chamber (< 2.0 mm). Participation in any other drug or device clinical trial within 30 days prior to enrolling this study and/or during study participation. Pregnancy or lactation. Subject who, in the judgment of the clinical investigator, is not suitable for participation in the study for any clinical reason, as documented by the investigator on the patient's Case Report Forms - CRFs).

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, single-arm, two-center interventional study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Eyedeal® IOL<br>Eyedeal® Model PX65AS1 IOL | Procedure: Cataract surgery<br>* Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.<br>Device: Eyedeal® Model PX65AS1 IOL<br>* Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EFFICACY OUTCOME MEASURE - Uncorrected Distance Visual Acuity | Uncorrected distance Visual Acuity is measured in accordance with ISO 11979-7:2018 - Appendix E: BCVA 20/40 or better in 95% of cases. The stability and consistency of visual results will be measured over time. | 12 months | 
| SAFETY OUTCOME MEASURE - Best Corrected Visual Acuity | The safety of the Eyedeal® Model PX65AS1 IOLs (Xi'an Eyedeal Medical Technology Co., Ltd.) will be measured by the following criteria: Loss of BCDVA measured in accordance with ISO 11979-7:2018-Appendix E | 12 months | 
| SAFETY OUTCOME MEASURE - Evaluation of Patient record | The safety of the Eyedeal® Model PX65AS1 IOLs (Xi'an Eyedeal Medical Technology Co., Ltd.) will be measured by the following criteria: Patient record of inflammation, discomfort, or pain following surgery related to the Eyedeal® Model PX65AS1 IOL (Xi'an Eyedeal Medical Technology Co., Ltd.) . . | 12 months | 
| SAFETY OUTCOME MEASURE - Evaluation of Adverse Events | The safety of the Eyedeal® Model PX65AS1 IOLs (Xi'an Eyedeal Medical Technology Co., Ltd.) will be measured by the following criteria: Evaluation of all adverse events, adverse device effects and device deficiencies at post-operative examinations | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract, Intraocular lens, IOL