AzTrials
AzTrials

Lens Implantation, IntraocularNCT05776095

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

A study testing Cataract surgery and Eyedeal® Model PX65AS1 IOL in people with Lens Implantation, Intraocular, run by Xi'an Eyedeal Medical Technology Co., Ltd at 2 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 22 years and older
Conditions the study is for
Lens Implantation, Intraocular
What is being tested?
Cataract surgery and Eyedeal® Model PX65AS1 IOL
Could I receive a placebo?
No, everyone receives an active treatment
How many people
97 participants
Where
2 sitesin 2 countries
Study dates
10 Nov 2023to 28 Feb 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 11Show fewer
  • 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).

Who cannot join

  • 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.
Show all 22Show fewer
  • 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).

Trial locations and contacts

2 sites in 2 countries.

Q. Trin Peng, MD contact

+86 029 848 88888

info@eyedeal.com

2 sites in 2 countries

Germany1 site, 1 recruiting

  • University Eye Clinic Heidelberg

    Heidelberg, Baden-Wurttemberg, 69120

    Raquel Willrich Amroussi, MA

    Prof. Dr. med. Gerd U. Auffarth, MD PHD

    Not yet recruiting

Other trials in Germany

Lithuania1 site, 1 recruiting

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

    Kaunas, 50161

    Eglė Karinauskė, MD

    Prof. Reda Žemaitienė, MD, PHD

    Recruiting

Other trials in Lithuania

About this study

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

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.

Read the 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 (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.

Being tested
Cataract surgery, Eyedeal® Model PX65AS1 IOL
Keywords
Cataract, Intraocular lens, IOL
Medical subject headings
Cataract

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cataract surgeryProcedure or surgery

    Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.

  • Eyedeal® Model PX65AS1 IOLDevice

    Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® Model PX65AS1 IOL in the eye capsule.

Study groups in NCT05776095
Study groupRoleWhat they receive
Eyedeal® IOLExperimentalEyedeal® Model PX65AS1 IOL
Receives: Procedure: Cataract surgery; Device: Eyedeal® Model PX65AS1 IOL

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 months

  2. 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

    Measured: 12 months

  3. 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.) .

    .

    Measured: 12 months

  4. 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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Mar 2023
  2. Study start10 Nov 2023
  3. Primary completion28 Feb 2025 (estimated)
  4. Study completion28 Feb 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Prospective, single-arm, two-center interventional study
Masking
None (open label)
Enrolment
97 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05776095
Sponsor's protocol ID
EU-301
Status last verified
Jan 2024
First submitted
17 Feb 2023
Last updated
2 Feb 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Cataract surgery and Eyedeal® Model PX65AS1 IOL in people with Lens Implantation, Intraocular, run by Xi'an Eyedeal Medical Technology Co., Ltd at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 2 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany, Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Q. Trin Peng, MD (+86 029 848 88888, info@eyedeal.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

EFFICACY OUTCOME MEASURE - Uncorrected Distance Visual Acuity (time frame: 12 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05776095.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in