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New lens implant shows promise for cataract patients

NCT ID NCT05646004

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study tested a new lens called 621 in 105 adults having cataract surgery. The lens was implanted during standard surgery to replace the cloudy natural lens. Researchers checked how well patients could see 6 months after surgery and monitored for any safety issues. The goal was to see if the lens is a safe and effective option for restoring clear vision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
621 intraocular lens implant
What this could lead to
If successful, this lens could provide a safe and effective option for restoring vision after cataract surgery.
What could go wrong
This was a small, single-arm study with no comparison group. Long-term benefits and rare risks are not fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

105 people

The number who actually took part.

Started

Jan 2023

Finished

Nov 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion: 1. Age ≥ 18 years old; 2. Patient with clinically significant cataract with planned phacoemulsification cataract extraction and implantation of IOL into the capsular bag; 3. Preoperative corneal astigmatism ≤ 1.00D; 4. Patient is willing and capable of providing informed consent; 5. Patient is willing and capable of complying with visits and procedures as defined by this protocol. Exclusion: 1. Preoperative best corrected visual acuity \> 4.7 or ≤ 0.3 logMAR; 2. Corneal endothelial cell count less than 2000 cell/mm2; 3. Age under 18 years old; 4. Pregnant and lactating women; 5. Patients who attend other drug or medical device study; 6. Ocular disorder that could potentially cause a clinically significant future visual acuity loss; 7. Anterior segment pathology (e.g. chronic uveitis, iritis, aniridia, rubeosis iridis, anterior membrane dystrophies, poor pupil dilation, etc.) 8. Abnormal corneal finding (e.g. keratoconus, pellucid marginal degeneration, or irregular astigmatism, clinically significant corneal membrane dystrophies); 9. Any condition in the study eye that could affect IOL stability (e.g. pseudo-exfoliation, zonular dialysis, evident zonular weakness or dehiscence, etc; 10. Any acute infection (acute ocular disease, external/internal infection, systemic infection); 11. History of any clinically significant retinal pathology or ocular diagnosis (e.g. diabetic retinopathy, ischemic diseases, macular degeneration, retinal detachment, optic neuropathy, amblyopia, strabismus, microphthalmia, aniridia, epiretinal membrane etc.) in the study eye that could alter or limit final postoperative visual prognosis; 12. Any previous intraocular and corneal surgery ; 13. Uncontrolled glaucoma or IOP higher than 24mmHg under ocular hypertension treatment; 14. Current systemic or ocular pharmacotherapy that effects patients' vision; 15. Current pathology or condition that could be a risk for the patient according to the investigator opinion; 16. Patients unable to meet the limitations of the protocol or likely of non-cooperation during the clinical investigation; 17. Patients whose freedom is impaired by administrative or legal order.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Hainan Boao Lecheng Aier Eye Hospital

    Qionghai, Hainan, China

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