Lens DiseasesNCT07321756
Evaluating Presbyopia-Correcting IOLs in Complex Cataract Cases With Anterior Segment Abnormalities
A study testing Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL and Unilateral Posterior Chamber Implantation of Monofocal IOL in people with Lens Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lens Diseases
- What is being tested?
- Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL and Unilateral Posterior Chamber Implantation of Monofocal IOL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 17 Nov 2025to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to 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;
Show all 32Show fewer
- 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.
Who cannot join
- 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)
Show all 26Show fewer
- 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 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.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang
Wen Xu, Phd, 86+ 13858185223, xuwen2003@zju.edu.cn
About this study
Official title: Clinical Study on the Application of Presbyopia-correcting Intraocular Lenses in the Surgery of Cataract Patients With Combined Anterior Segment Structural Abnormalities
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. However, there is a growing demand among these patients for improved visual quality and spectacle independence.Currently, various presbyopia-correcting IOLs offer distinct advantages, providing more personalized options. The introduction and application of intraoperative optical coherence tomography (iOCT) ensures effective intraoperative monitoring. These advances make the precise implantation of presbyopia-correcting IOLs a promising extension to phacoemulsification in complex cataracts with anterior segment abnormalities.
Nevertheless, their exact benefits regarding visual quality, safety, and patient satisfaction require systematic evaluation through rigorous prospective studies and long-term follow-up. Under strict perioperative management, this study will employ iOCT to monitor the accurate implantation of presbyopia-correcting IOLs and will assess postoperative visual quality and patient satisfaction.
Read the detailed description
With the evolution of refractive cataract surgery, the goal of treatment has progressed from simple visual rehabilitation to providing clear and comfortable full-range vision through the implantation of functional intraocular lenses (IOLs). Traditionally, monofocal IOLs have been the standard choice for patients with anterior segment abnormalities-such as lens subluxation, cataract with a history of chronic anterior uveitis, post-laser refractive surgery cataract, or aphakia with insufficient capsular support-to minimize adverse optical outcomes. However, these patients, who span a broad age range, increasingly desire high postoperative visual quality and reduced spectacle dependence. Modern presbyopia-correcting IOLs offer advantages in material properties, structural design, and optical performance, improving biocompatibility and reducing visual disturbances such as glare and halos, thereby expanding personalized options. The integration of intraoperative optical coherence tomography (iOCT) further enhances the precision and safety of IOL implantation.
Based on these advancements, the precise implantation of presbyopia-correcting IOLs holds promise for complex cataract cases with anterior segment abnormalities. Nevertheless, their efficacy, safety, and impact on patient satisfaction require systematic evaluation through well-designed prospective studies. This prospective study aims to assess the clinical outcomes of precisely implanted presbyopia-correcting IOLs in patients with complex cataract and anterior segment structural abnormalities, including lens subluxation, chronic anterior uveitis, post-refractive surgery status, and aphakia with inadequate capsular support. Utilizing iOCT for real-time monitoring of anterior segment anatomy, capsular stability, and effective lens position (ELP) during surgery, the study will compare visual quality, safety parameters, and patient satisfaction between presbyopia-correcting IOLs and conventional monofocal IOLs, providing evidence to support individualized IOL selection in this population.
- Conditions
- Lens Diseases
- Being tested
- Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL, Unilateral Posterior Chamber Implantation of Monofocal IOL
- Medical subject headings
- Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOLProcedure or surgery
Based on the specific characteristics and needs of each of the four patient groups, a suitable presbyopia-correcting IOL will be selected and precisely implanted unilaterally in the posterior chamber.
Unilateral Posterior Chamber Implantation of Monofocal IOLProcedure or surgery
Each control group will undergo unilateral posterior chamber implantation of the same-brand monofocal IOL as used in the experimental group, following conventional selection criteria.
| Study group | Role | What they receive |
|---|---|---|
| Unilateral Posterior Chamber Presbyopia-Correcting IOL Implantation Group | Experimental | This arm includes four cohorts of cataract patients with different types of anterior segment structural abnormalities: the lens subluxation group, the chronic anterior uveitis with cataract group, the post-myopic laser corneal surgery with cataract group, and the aphakia with insufficient capsular support group. Patients in each group will undergo unilateral posterior chamber implantation of a suitable type of presbyopia-correcting IOL based on their individual characteristics. Receives: Procedure: Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL |
| Unilateral Posterior Chamber Monofocal IOL Implantation Group | Active comparator | This arm includes four cohorts of cataract patients with different types of anterior segment structural abnormalities: the lens subluxation group, the chronic anterior uveitis with cataract group, the post-myopic laser corneal surgery with cataract group, and the aphakia with insufficient capsular support group. Patients in each control group will undergo unilateral posterior chamber implantation of a monofocal IOL of the same brand as that used in the experimental group. Receives: Procedure: Unilateral Posterior Chamber Implantation of Monofocal IOL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Uncorrected Distance Visual Acuity (UDVA)
Visual acuity measured at distance（at 5m) without correction.
Measured: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months.
Effective Lens Position (ELP)
ELP determined by IOLMaster 700, anterior segment optical coherence tomography (AS-OCT), and anterior segment photography.
Measured: Baseline, and postoperatively at 1 month, and 3 months
Contrast sensitivity (at 2.5 m)
Uncorrected binocular contrast sensitivity was recorded under mesopic, mesopic with glare, photopic, and photopic with glare conditions at spatial frequencies of 3, 6, 12, and 19 cpd.）
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Defocus curve (at 5 m)
Defocus curves were obtained monocularly and binocularly under uncorrected vision with a micro-monovision setup. Acuity was recorded across 13 refractive intervals from +2.00 D to -4.00 D in 0.50 D decrements.
Measured: Preoperatively, and postoperatively at 1 month and 3 months
Optical visual quality
Visual symptoms (glare/halos/starburst) assessed via QoV questionnaire
Measured: Postoperatively at 1 week, 1 month, and 3 months
Visual Function Assessment
Visual Function Index-14 Chinese Version (VF-14-CN) Questionnaire
Measured: Postoperatively at 1 week, 1 month, and 3 months
Best Corrected Visual Acuity (BCVA)
Best Corrected Visual Acuity at distance (at 5m)
Measured: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Uncorrected Intermediate Visual Acuity (UIVA)
Uncorrected visual acuity (UCVA) at intermediate.
Measured: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Uncorrected Near Visual Acuity (UNVA)
Uncorrected visual acuity (UCVA) at near (at 40 cm).
Measured: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Secondary outcomes (7)
Intraocular pressure (IOP)
Intraocular pressure (IOP) measured by non-contact tonometer.(mmHg)
Measured: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Pupil Diameter
Measuring Pupil Diameter
Measured: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Ocular B-scan ultrasound
Measured: Preoperatively, and postoperatively at 1 month and 3 months
Dry Eye Assessment
Dry eye assessment via Tear Film Break-Up Time (TFBUT)
Measured: Preoperatively, and postoperatively at1 week, 1 month, and 3 months
Fundus assessment
Fundus assessment via fundus photography and macular optical coherence tomography (OCT).
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Endothelial cell density
Endothelial cell density（%）
Measured: Preoperatively and postoperatively 1 month
Frequency of using glasses
Frequency ratings for the use of corrective glasses at a distance, medium range, and close range.
Measured: Postoperatively at 1 week, 1 month, and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start17 Nov 2025
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lens DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 320 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wen Xu, Phd, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07321756
- Sponsor's protocol ID
- 2025-1077
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Application of Presbyopia-correcting Intraocular Lenses in the Surgery of Cataract Patients With Combined Anterior Segment Structural Abnormalities
- ClinicalTrials.gov ID
- NCT07321756
- Acronym / sponsor ID
- 2025-1077
- Conditions
- Lens Diseases
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 320 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 17 Nov 2025 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. However, there is a growing demand among these patients for improved visual quality and spectacle independence.Currently, various presbyopia-correcting IOLs offer distinct advantages, providing more personalized options. The introduction and application of intraoperative optical coherence tomography (iOCT) ensures effective intraoperative monitoring. These advances make the precise implantation of presbyopia-correcting IOLs a promising extension to phacoemulsification in complex cataracts with anterior segment abnormalities.
Nevertheless, their exact benefits regarding visual quality, safety, and patient satisfaction require systematic evaluation through rigorous prospective studies and long-term follow-up. Under strict perioperative management, this study will employ iOCT to monitor the accurate implantation of presbyopia-correcting IOLs and will assess postoperative visual quality and patient satisfaction.
Detailed description
With the evolution of refractive cataract surgery, the goal of treatment has progressed from simple visual rehabilitation to providing clear and comfortable full-range vision through the implantation of functional intraocular lenses (IOLs). Traditionally, monofocal IOLs have been the standard choice for patients with anterior segment abnormalities-such as lens subluxation, cataract with a history of chronic anterior uveitis, post-laser refractive surgery cataract, or aphakia with insufficient capsular support-to minimize adverse optical outcomes. However, these patients, who span a broad age range, increasingly desire high postoperative visual quality and reduced spectacle dependence. Modern presbyopia-correcting IOLs offer advantages in material properties, structural design, and optical performance, improving biocompatibility and reducing visual disturbances such as glare and halos, thereby expanding personalized options. The integration of intraoperative optical coherence tomography (iOCT) further enhances the precision and safety of IOL implantation.
Based on these advancements, the precise implantation of presbyopia-correcting IOLs holds promise for complex cataract cases with anterior segment abnormalities. Nevertheless, their efficacy, safety, and impact on patient satisfaction require systematic evaluation through well-designed prospective studies. This prospective study aims to assess the clinical outcomes of precisely implanted presbyopia-correcting IOLs in patients with complex cataract and anterior segment structural abnormalities, including lens subluxation, chronic anterior uveitis, post-refractive surgery status, and aphakia with inadequate capsular support. Utilizing iOCT for real-time monitoring of anterior segment anatomy, capsular stability, and effective lens position (ELP) during surgery, the study will compare visual quality, safety parameters, and patient satisfaction between presbyopia-correcting IOLs and conventional monofocal IOLs, providing evidence to support individualized IOL selection in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unilateral Posterior Chamber Presbyopia-Correcting IOL Implantation Group | Experimental | Procedure: Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOLThis arm includes four cohorts of cataract patients with different types of anterior segment structural abnormalities: the lens subluxation group, the chronic anterior uveitis with cataract group, the post-myopic laser corneal surgery with cataract group, and the aphakia with insufficient capsular support group. Patients in each group will undergo unilateral posterior chamber implantation of a suitable type of presbyopia-correcting IOL based on their individual characteristics. |
| Unilateral Posterior Chamber Monofocal IOL Implantation Group | Active comparator | Procedure: Unilateral Posterior Chamber Implantation of Monofocal IOLThis arm includes four cohorts of cataract patients with different types of anterior segment structural abnormalities: the lens subluxation group, the chronic anterior uveitis with cataract group, the post-myopic laser corneal surgery with cataract group, and the aphakia with insufficient capsular support group. Patients in each control group will undergo unilateral posterior chamber implantation of a monofocal IOL of the same brand as that used in the experimental group. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (32 listed)
- Lens Subluxation Unilateral Implantation Group
- Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group
- Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group
- Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group
Key exclusion criteria (26 listed)
- Lens Subluxation Unilateral Implantation Group
- Inactive Long-standing Anterior Uveitis with Cataract Unilateral Implantation Group
- Post-myopic Laser Corneal Surgery with Cataract Unilateral Implantation Group
- Aphakia with Insufficient Residual Capsular Support Unilateral Implantation Group
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOLBased on the specific characteristics and needs of each of the four patient groups, a suitable presbyopia-correcting IOL will be selected and precisely implanted unilaterally in the posterior chamber. | Procedure or surgery | Unilateral Posterior Chamber Presbyopia-Correcting IOL Implantation Group |
| Unilateral Posterior Chamber Implantation of Monofocal IOLEach control group will undergo unilateral posterior chamber implantation of the same-brand monofocal IOL as used in the experimental group, following conventional selection criteria. | Procedure or surgery | Unilateral Posterior Chamber Monofocal IOL Implantation Group |
Primary outcome
Uncorrected Distance Visual Acuity (UDVA)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months.
Visual acuity measured at distance（at 5m) without correction.
Effective Lens Position (ELP)
Time frame: Baseline, and postoperatively at 1 month, and 3 months
ELP determined by IOLMaster 700, anterior segment optical coherence tomography (AS-OCT), and anterior segment photography.
Contrast sensitivity (at 2.5 m)
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Uncorrected binocular contrast sensitivity was recorded under mesopic, mesopic with glare, photopic, and photopic with glare conditions at spatial frequencies of 3, 6, 12, and 19 cpd.）
Defocus curve (at 5 m)
Time frame: Preoperatively, and postoperatively at 1 month and 3 months
Defocus curves were obtained monocularly and binocularly under uncorrected vision with a micro-monovision setup. Acuity was recorded across 13 refractive intervals from +2.00 D to -4.00 D in 0.50 D decrements.
Optical visual quality
Time frame: Postoperatively at 1 week, 1 month, and 3 months
Visual symptoms (glare/halos/starburst) assessed via QoV questionnaire
Visual Function Assessment
Time frame: Postoperatively at 1 week, 1 month, and 3 months
Visual Function Index-14 Chinese Version (VF-14-CN) Questionnaire
Best Corrected Visual Acuity (BCVA)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Best Corrected Visual Acuity at distance (at 5m)
Uncorrected Intermediate Visual Acuity (UIVA)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Uncorrected visual acuity (UCVA) at intermediate.
Uncorrected Near Visual Acuity (UNVA)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Uncorrected visual acuity (UCVA) at near (at 40 cm).
7 secondary outcomes
Intraocular pressure (IOP)
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Pupil Diameter
Time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months
Ocular B-scan ultrasound
Time frame: Preoperatively, and postoperatively at 1 month and 3 months
Dry Eye Assessment
Time frame: Preoperatively, and postoperatively at1 week, 1 month, and 3 months
Fundus assessment
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Endothelial cell density
Time frame: Preoperatively and postoperatively 1 month
Frequency of using glasses
Time frame: Postoperatively at 1 week, 1 month, and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Wen Xu, Phd principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Unilateral Posterior Chamber Implantation of Presbyopia-Correcting IOL and Unilateral Posterior Chamber Implantation of Monofocal IOL in people with Lens Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 32 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wen Xu, Phd (86+13858185223, xuwen2003@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Uncorrected Distance Visual Acuity (UDVA) (time frame: Preoperatively, and postoperatively at 1 day, 1 week, 1 month, and 3 months.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.