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New treatment option for Lens Diseases
Official title Evaluating Presbyopia-Correcting IOLs in Complex Cataract Cases With Anterior Segment Abnormalities
ClinicalTrials.gov ID: NCT07321756
What this study is testing
- What it's testing
- The goal of cataract surgery has evolved from simply restoring sight to providing clear and comfortable full-range vision. Traditionally, monofocal IOLs remain the routine choice for special cases with anterior segment abnormalities-such as lens subluxation, cataract with chronic uveitis, post-laser refractive cataract, and aphakia with insufficient capsular support.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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;
You likely can't join if
- 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...
- 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)
See the full eligibility criteria
Who can join
- 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.
- 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.
- 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.
- 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.
What rules you out
- 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...
- 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.
- 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...
- 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.
- 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...
- 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.