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

Last updated: January 31, 2024
Sponsor: Xi'an Eyedeal Medical Technology Co., Ltd
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Eye Disorders/infections

Eye Disease

Treatment

Eyedeal® Model PX65AS1 IOL

Cataract surgery

Clinical Study ID

NCT05776095
EU-301
  • Ages > 22
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 byInvestigator'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, astatement of IRB or EC approved Informed Consent Form (ICF).

Exclusion

Exclusion Criteria:

  1. Any type of cataract (e.g., traumatic, congenital, polar) other than those noted ininclusion criteria.
  2. Ocular conditions which could affect the stability of the IOL (e.g.,pseudoexfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc.) inthe study eye.
  3. Any anterior segment pathology likely to increase the risk of complications fromphacoemulsification cataract extraction (e.g., chronic uveitis, iritis, iridocyclitis,aniridia, rubeosis iridis, clinically significant corneal disorders, (Fuch's, oranterior basement membrane dystrophy, etc.) in the study eye.
  4. Mature cataract that is likely to prolong phacoemulsification and/or lead tointraoperative complications prior to attempted IOL implantation.
  5. Any visually significant intraocular media opacity other than cataract in the studyeye.
  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 postoperativevisual 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 toobtain 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 originthat, in the opinion of the investigator, could confound outcomes.
  13. Abnormal corneal findings in either eye (e.g. keratoconus, pellucid marginaldegeneration, 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'shealth 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 outcomeor increase the intraoperative and post-operative risk to the subject (e.g.,tamsulosin hydrochloride) or other medications including anticholinergics, alphaadrenergic blocking agents with similar side effects (e.g., small pupil/floppy irissyndrome).
  16. Subjects who may reasonably be expected to require any additional ophthalmic surgicalintervention 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 toenrolling this study and/or during study participation.
  21. Pregnancy or lactation.
  22. Subject who, in the judgment of the clinical investigator, is not suitable forparticipation in the study for any clinical reason, as documented by the investigatoron the patient's Case Report Forms - CRFs).

Study Design

Total Participants: 97
Treatment Group(s): 2
Primary Treatment: Eyedeal® Model PX65AS1 IOL
Phase:
Study Start date:
November 10, 2023
Estimated Completion Date:
February 28, 2025

Study 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 (PX65AS1) is a foldable single-piece ultra-violet absorbing posterior chamber intraocular lens (IOL). It is an optical implant to replace the human crystalline lens in the visual correction of aphakia in adult patients after cataract removal. The Eyedeal® PX65AS1 IOL lens is made of a high refractive index soft cross-linked polyolefin. The Eyedeal® PX65AS1 IOL lens has an aspheric optic with symmetric optic design and spherical neutral and correct lens's own spherical aberration supporting haptics to provide proper position of the IOL optic within the capsule.

Connect with a study center

  • University Eye Clinic Heidelberg

    Heidelberg, Baden-Wuerttemberg 69120
    Germany

    Site Not Available

  • Department of Ophthalmology, Hospital of Lithuanian University of Health Sciences Kauno klinikos

    Kaunas, 50161
    Lithuania

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.