New lens implant shows promise for cataract patients
NCT ID NCT05646004
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
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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
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105 people
The number who actually took part.
- Started
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Jan 2023
- Finished
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Nov 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Hainan Boao Lecheng Aier Eye Hospital
Qionghai, Hainan, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.