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

Launched by XI'AN EYEDEAL MEDICAL TECHNOLOGY CO., LTD · Mar 7, 2023

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of lens called the Eyedeal® IOL, which is used to replace the cloudy natural lens in the eye after cataract surgery. Cataracts are common as people age and can make it hard to see clearly. The study aims to ensure that this new lens can be safely implanted and works effectively to restore vision. If you are an adult aged 22 or older and have been diagnosed with age-related cataracts that affect your vision, you may be eligible to participate.

Participants in the trial will need to attend a total of seven visits over the year following their surgery. During these visits, doctors will monitor your eye health and vision to see how well the Eyedeal® lens is performing. It’s important for participants to be willing to complete all follow-up visits and to understand the consent process. This study could potentially help improve cataract treatment options for many people in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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.
• • 2. Preoperative best corrected distance visual acuity (BCDVA) of 20/32 or worse.
• • 3. Projected postoperative BCDVA 0.20 logMAR or better in the study eye, as determined by Investigator's medical judgment.
• • 4. Calculated spherical power targeted at emmetropia at distance in the study eye.
• • 5. Calculated lens power within the available range for the Eyedeal® Model PX65AS1 IOL (+0.50D - +34.00D).
• • 6. Planned cataract removal by phacoemulsification procedure.
• • 7. Clear intraocular media other than cataract, in the study eye.
• • 8. Pharmacologically dilated pupil size of at least 6.0mm.
• • 9. 2.0 D or less of preoperative astigmatism in the study eye.
• • 10. Willing and able to complete all required postoperative visits.
• • 11. 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:
• • 1. Any type of cataract (e.g., traumatic, congenital, polar) other than those noted in inclusion criteria.
• • 2. 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.
• • 3. 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.
• • 4. Mature cataract that is likely to prolong phacoemulsification and/or lead to intraoperative complications prior to attempted IOL implantation.
• • 5. Any visually significant intraocular media opacity other than cataract in the study eye.
• • 6. 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.
• • 7. History of any intraocular, retinal, corneal or refractive surgery in the study eye (including LASIK, PRK, LRI, etc.).
• • 8. History of cystoid macular edema in the study eye.
• • 9. History of serious corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.) in either eye.
• • 10. Severe dry eye that, in the opinion of the investigator, would impair the ability to obtain reliable study measurements.
• • 11. Uncontrolled glaucoma and/or optic atrophy in the study eye.
• • 12. Subjects with large refractive errors (hyperopia/myopia) of axial or pathologic origin that, in the opinion of the investigator, could confound outcomes.
• • 13. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism).
• • 14. 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.
• • 15. 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).
• • 16. Subjects who may reasonably be expected to require any additional ophthalmic surgical intervention at any time during the study (other than YAG capsulotomy).
• • 17. Need for concomitant procedures (e.g., glaucoma surgery, LRI, RK, LASIK, etc.).
• • 18. Fellow eye BCDVA worse than 1.0 logMAR.
• • 19. Extremely shallow anterior chamber (\< 2.0 mm).
• • 20. Participation in any other drug or device clinical trial within 30 days prior to enrolling this study and/or during study participation.
• • 21. Pregnancy or lactation.
• • 22. 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).