CataractNCT06223113
Evaluation of Safety and Performance of the EyenableTM Intraocular Lens for Cataract Treatment
A study testing EyenableTM PA60AS1 IOL in people with Cataract, run by Xi'an Eyedeal Medical Technology Co., Ltd.
Trial summary
Cataract is characterized by the loss of the normal transparency of the crystalline lens. It is a progressive, chronic disease that affect individuals over the age of 50. It is the leading cause of blindness around the world. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cataract
- What is being tested?
- EyenableTM PA60AS1 IOL
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2024to 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (≥ 18 years of age at the time of surgery) of any gender, diagnosed with age related cataracts in one or both eyes.
- Opacity of crystalline lens due to cataract and reduced vision assessed by patient complaints.
- Calculated lens power within the available range for the EyenableTM PA60AS1 IOL (+10D to +30.00D)
- 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.
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- 2.0 D or less of preoperative astigmatism in the study eye
- Willing and able to complete all required postoperative visits
- Able and willing to comprehend and sign or through a representative, with a witness present, an EC approved Informed Consent Form (ICF).
Who cannot join
- 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).
- Any type of cataract other than age-related.
- History of any intraocular, retinal, corneal or refractive surgery in the study eye (including LASIK, PRK, SMILE, etc.), only in the opinion of investigator that it could confound study outcome
- 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, (Fuchs', 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.
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- 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 cystoid macular edema in the study 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.
- Extremely shallow anterior chamber (< 2.0 mm).
- 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)
- 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, PRK, LASIK, etc.).
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Prospective, Registry-based Study to Evaluate Safety and Performance of EyenableTM Intraocular Lens Implantation After Cataract Removal
Cataract is characterized by the loss of the normal transparency of the crystalline lens. It is a progressive, chronic disease that affect individuals over the age of 50. It is the leading cause of blindness around the world. The EyenableTM IOL (PA60AS1) is a CE-marked 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. This post-market clinical study will investigate the implantation safety and performance of the EyenableTM PA60AS1 intraocular lens (IOL) up to 6 month after the surgery.
- Conditions
- Cataract
- Being tested
- EyenableTM PA60AS1 IOL
- Keywords
- Intraocular lens
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EyenableTM PA60AS1 IOLDevice
Subjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® EyenableTM PA60AS1 IOL in the eye capsule.
| Study group | Role | What they receive |
|---|---|---|
| EyenableTM PA60AS1 IOL implanation | Other | IOL implantation Receives: Device: EyenableTM PA60AS1 IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
SAFETY OUTCOME MEASURE - Adverse event
The primary safety endpoints include rates of adverse events, loss of CDVA, slit lamp examination, fundus examination, intraocular pressure, device deficiencies.
Measured: 6 month after the device implantation.
PERFORMANCE OUTCOME MEASURE - uncorrected distance visual acuity (UCDVA)
Measurement of UCDVA
Measured: 6 month after the device implantation
PERFORMANCE OUTCOME MEASURE - Corrected distance visual acuity (CDVA)
Measurement of CDVA
Measured: 6 month after the device implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2024
- Study startFeb 2024 (estimated)
- Primary completionFeb 2025 (estimated)
- Study completionFeb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CataractStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xi'an Eyedeal Medical Technology Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06223113
- Sponsor's protocol ID
- 201-REG
- Status last verified
- Jan 2024
- First submitted
- 16 Jan 2024
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Registry-based Study to Evaluate Safety and Performance of EyenableTM Intraocular Lens Implantation After Cataract Removal
- ClinicalTrials.gov ID
- NCT06223113
- Acronym / sponsor ID
- 201-REG
- Conditions
- Cataract
- Keywords
- Intraocular lens
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xi'an Eyedeal Medical Technology Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2024 (estimated)
- Primary completion
- Feb 2025 (estimated)
- Study completion
- Feb 2025 (estimated)
- First posted
- 25 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Cataract is characterized by the loss of the normal transparency of the crystalline lens. It is a progressive, chronic disease that affect individuals over the age of 50. It is the leading cause of blindness around the world. The EyenableTM IOL (PA60AS1) is a CE-marked 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. This post-market clinical study will investigate the implantation safety and performance of the EyenableTM PA60AS1 intraocular lens (IOL) up to 6 month after the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EyenableTM PA60AS1 IOL implanation | Other | Device: EyenableTM PA60AS1 IOLIOL implantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adults (≥ 18 years of age at the time of surgery) of any gender, diagnosed with age related cataracts in one or both eyes.
- Opacity of crystalline lens due to cataract and reduced vision assessed by patient complaints.
- Calculated lens power within the available range for the EyenableTM PA60AS1 IOL (+10D to +30.00D)
- Planned cataract removal by phacoemulsification procedure
- Clear intraocular media other than cataract, in the study eye
Key exclusion criteria (19 listed)
- 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).
- Any type of cataract other than age-related.
- History of any intraocular, retinal, corneal or refractive surgery in the study eye (including LASIK, PRK, SMILE, etc.), only in the opinion of investigator that it could confound study outcome
- 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, (Fuchs', or anterior basement membrane dystrophy, etc.) in the study eye.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EyenableTM PA60AS1 IOLSubjects will undergo surgery to remove cataract (the cloudy lenses) via phacoemulsification, and implant the Eyedeal® EyenableTM PA60AS1 IOL in the eye capsule. | Device | EyenableTM PA60AS1 IOL implanation |
Primary outcome
SAFETY OUTCOME MEASURE - Adverse event
Time frame: 6 month after the device implantation.
The primary safety endpoints include rates of adverse events, loss of CDVA, slit lamp examination, fundus examination, intraocular pressure, device deficiencies.
PERFORMANCE OUTCOME MEASURE - uncorrected distance visual acuity (UCDVA)
Time frame: 6 month after the device implantation
Measurement of UCDVA
PERFORMANCE OUTCOME MEASURE - Corrected distance visual acuity (CDVA)
Time frame: 6 month after the device implantation
Measurement of CDVA
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing EyenableTM PA60AS1 IOL in people with Cataract, run by Xi'an Eyedeal Medical Technology Co., Ltd.
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 9 inclusion and 19 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 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
SAFETY OUTCOME MEASURE - Adverse event (time frame: 6 month after the device implantation.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Feb 2024.