Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07321756
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT07321756
Study Brief:
Protocol Section:
NCT07321756