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New lens implants promise clearer vision for complex cataract cases

NCT ID NCT07321756

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests special lens implants that correct both cataracts and presbyopia (age-related blurry near vision) in patients with additional eye structure issues like lens dislocation or inflammation. About 320 adults will receive these lenses during cataract surgery, with doctors using advanced imaging to ensure precise placement. The goal is to see if these lenses improve vision quality and reduce the need for glasses, while monitoring safety and satisfaction over time.

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

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 80 years

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 Criteria: 1. Lens Subluxation Unilateral Implantation Group * Patients aged 18-80 years with diagnosed lens subluxation meeting surgical indications for lens surgery, enrolled unilaterally; * Informed consent for the study; * Ability to comply with full follow-up; * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm; * Mesopic natural pupil diameter between 3.0 mm and 5.5 mm; * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D; * Subjective desire to improve full-range visual function. 2. Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group * Patients aged 18-80 years with diagnosed inactive long-standing anterior uveitis (quiet for ≥3 months) and cataract meeting surgical indications for lens surgery, enrolled unilaterally; * Centered pupil without significant deformity, with expected postoperative mesopic natural pupil diameter between 2.5 mm and 5.5 mm; * Informed consent for the study; * Ability to comply with full follow-up; * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm; * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D; * Subjective desire to improve full-range visual function. 3. Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group * Patients aged 18-80 years with cataract following prior myopic laser corneal surgery meeting surgical indications for lens surgery, enrolled unilaterally; * Informed consent for the study; * Ability to comply with full follow-up; * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm; * Mesopic natural pupil diameter between 3.0 mm and 5.5 mm; * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D; * Subjective desire to improve full-range visual function. 4. Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group * Patients aged 18-80 years with aphakia and insufficient residual capsular support meeting surgical indications for IOL implantation, enrolled unilaterally; * Informed consent for the study; * Ability to comply with full follow-up; * Kappa angle \<0.5 mm, total higher-order aberration root mean square (HOA RMS) within the central 4-mm corneal zone \<1 μm; * Mesopic natural pupil diameter between 3.0 mm and 5.5 mm; * Expected postoperative astigmatism ≤1.0 D, with target spherical equivalent between 0.00 D and ±0.75 D; * Subjective desire to improve full-range visual function. Exclusion Criteria: 1. Lens Subluxation Unilateral Implantation Group * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea. * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders. * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, significant pupillary abnormalities (excessively large or small pupils), severe corneal disease or scarring, high irregular astigmatism, chronic uveitis, or severe amblyopia. * Patients with lens disorders other than subluxation and cataract. * Patients experiencing intraoperative complications that may affect IOL position and outcome (e.g., posterior capsule rupture, iris prolapse) * Patients with a history of prior ocular surgery such as corneal refractive laser surgery, glaucoma surgery, or vitrectomy. 2. Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group * Patients with active systemic autoimmune diseases, or any systemic disease history or medication use known to significantly affect vision. * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea. * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders. * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, severe corneal disease or scarring, high irregular astigmatism, active uveitis, significant abnormalities of the lens capsule or zonules, or severe amblyopia. * Patients experiencing intraoperative complications that may affect IOL position and outcome (e.g., posterior capsule rupture, iris prolapse). * Patients with a history of prior ocular surgery such as corneal refractive laser surgery, glaucoma surgery, or vitrectomy. 3. Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea. * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders. * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, significant pupillary abnormalities (excessively large or small pupils), severe corneal disease, high irregular astigmatism, chronic uveitis, significant abnormalities of the lens capsule or zonules, or severe amblyopia. * Patients experiencing intraoperative complications that may affect IOL position or outcome (e.g., posterior capsule rupture, iris prolapse). * Patients with a history of prior ocular surgery such as glaucoma surgery or vitrectomy. 4. Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group * Patients with coexisting ocular developmental anomalies such as microphthalmos or microcornea. * Patients with severe or progressive ocular diseases (e.g., glaucoma, diabetic retinopathy, macular degeneration) or severe optic nerve disorders. * Patients with other organic ocular pathologies, including pathologic high myopia with fundus changes, significant pupillary abnormalities (excessively large or small pupils), severe corneal disease or scarring, high irregular astigmatism, chronic uveitis, or severe amblyopia. * Patients experiencing intraoperative complications that may affect IOL position or outcome (e.g., iris prolapse). * Patients with a history of prior ocular surgery such as corneal refractive laser surgery, glaucoma surgery, or posterior vitrectomy.

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.