New lens implants promise clearer vision for complex cataract cases
NCT ID NCT07321756
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 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 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Aphakia are added.
Genom att skicka in godkänner du våra Användarvillkor
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGHangzhou, Zhejiang, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- A lens that could let cataract patients see near and far without glasses
- One operation for cataract and glaucoma? eye surgeons test a Two-in-One approach
- Eye drops may shield the cornea after cataract surgery
- Can newer cataract lenses keep vision clear for years?
- A simple blood draw might reveal hidden eye lymphoma
- Can a new lens make glasses obsolete after cataract surgery?