Lens DiseasesNCT07321769
Full 3D Eye Modeling in the Diagnosis and Treatment of Lens Diseases With Eye Structures Disorders
An observational study of Lens Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
In patients with complex cataracts, spatial abnormalities in the lens and its surrounding tissues-including both the anterior and posterior ocular segments-are often present. Due to the lack of precise preoperative assessment tools and standardized surgical protocols, these cases are associated with increased surgical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Lens Diseases
- Type of treatment
- Injection or infusion
- How many people
- 1,200 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2025
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: The data for this project was collected from patients who visited the Second Affiliated Hospital, School of Medicine, Zhejiang University from January 1, 2020 to December 31, 2025.
Who may be able to join
- Part I：Toward 3D Modeling for Lens Disorders Associated with Congenital Anomalies
- 1) Diagnosed with lens disorders such as lens subluxation or deformity via imaging (slit-lamp, UBM) or clinical examination, combined with conditions such as megalocornea, microcornea, nanophthalmos, keratoconus, or iris coloboma; 2) Presence of imageable ocular structures; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, and anterior segment SS-OCT.
- Part II: Toward 3D Modeling for Reconstructive Management of Ocular Trauma 1) Diagnosed with previous or stabilized corneal trauma, traumatic cataract, or iris injury, with or without associated vitreous traction or retinal damage; 2) Patients with open globe injuries that have been managed, with closed wounds and no endophthalmitis; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, anterior segment SS-OCT, and CT.
- Part III:Toward 3D Modeling for IOL Spatial Positioning 1) Patients who have undergone cataract extraction with intraocular lens (IOL) implantation (in-the-bag or scleral-fixated); 2) Stable IOL position post-implantation with clear documentation of IOL parameters; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, and anterior segment SS-OCT.
- Part IV: Toward 3D Modeling for Cataracts with Iris/Pupillary Abnormalities
- Patients with iris morphological or positional abnormalities due to previous uveitis, trauma, or developmental anomalies (e.g., iris atrophy, synechiae, iridodialysis, polycoria, pupillary membrane remnants); 2) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, and anterior segment SS-OCT.
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- Part V: Toward 3D Modeling for Cataracts with Posterior Segment Diseases
- 1) Patients with various posterior segment vitreoretinal diseases (e.g., vitreous traction or proliferation, macular hole, epiretinal membrane), with or without anterior segment spatial structural abnormalities; 2) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, and anterior/posterior segment SS-OCT.
- Part VI: Normal Control Group
- No significant structural ocular diseases; 2) Healthy fellow eyes of unilateral ocular trauma patients from Part II, with no notable anterior or posterior segment abnormalities; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, anterior/posterior segment SS-OCT, and CT.
Who cannot join
- Part I: Toward 3D Modeling for Lens Disorders Associated with Congenital Anomalies
- 1) Concurrent open globe injury or severe ocular deformity; 2) Excessive corneal opacity or severe edema resulting in inadequate image quality; 3) Severe dry eye or tear film abnormalities affecting imaging;4) Severe ocular structural deformity preventing effective 3D model reconstruction; 5) Severe systemic disease precluding tolerance of the examination; 6) Contraindications to B-scan ultrasound or UBM, conditions impairing imaging, or allergy to coupling gel.
- Part II: Toward 3D Modeling for Reconstructive Management of Ocular Trauma
- 1) Unmanaged open globe injury or severe ocular deformity; 2) Severe systemic disease precluding tolerance of the examination; 3) Contraindications to CT imaging (e.g., metallic implants in the head/face region, pregnancy, lactation) or history of contrast medium allergy/adverse reactions.
- Part III: Toward 3D Modeling for IOL Spatial Positioning
- 1) Unclear IOL position or documented implantation failure; 2) Corneal opacity or severe pupillary abnormality affecting imaging; 3) IOL instability due to intra- or postoperative complications preventing imaging;4) Open globe injury or severe ocular deformity; 5) Severe systemic disease precluding tolerance of the examination; 6) Contraindications to B-scan ultrasound or UBM, conditions impairing imaging, or allergy to coupling gel.
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- Part IV: Toward 3D Modeling for Cataracts with Iris/Pupillary Abnormalities
- 1) Corneal opacity or hyphema preventing imaging; 2) Severe global ocular deformity precluding imaging; 3) Severe systemic disease precluding tolerance of examination or follow-up; 4) Contraindications to B-scan ultrasound or UBM, conditions impairing imaging, or allergy to coupling gel.
- Part V: Toward 3D Modeling for Cataracts with Posterior Segment Diseases
- 1) Severe structural deformity of both anterior and posterior segments preventing effective 3D model reconstruction; 2) Severe systemic disease precluding tolerance of examination or follow-up; 3) Contraindications to B-scan ultrasound or UBM, conditions impairing imaging, or allergy to coupling gel.
- Part VI: Normal Control Group 1) History of severe ocular trauma or ocular surgery; 2) Conditions affecting imaging quality, including corneal opacity, severe dry eye, tear film abnormalities, anterior segment disease, or significant retinal pathology; 3) Severe systemic disease precluding tolerance of the examination; 4) Contraindications to CT imaging (e.g., metallic implants in the head/face region, pregnancy, lactation) or history of contrast medium allergy/adverse reactions.
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, 310009
Wen Xu, Phd, 86+ 13858185223, xuwen2003@zju.edu.cn
About this study
In patients with complex cataracts, spatial abnormalities in the lens and its surrounding tissues-including both the anterior and posterior ocular segments-are often present. Due to the lack of precise preoperative assessment tools and standardized surgical protocols, these cases are associated with increased surgical complexity and difficulty, often leading to suboptimal visual outcomes. Therefore, this study explores a three-dimensional reconstruction method for the anterior segment based on swept-source optical coherence tomography (SS-OCT). By integrating imaging data from CT, B-scan ultrasound, and ultrasound biomicroscopy (UBM), a full three-dimensional model of the eye is constructed to enable objective and quantitative evaluation of its entire structure. This approach aims to provide valuable reference for surgical planning and prognostic assessment in lens diseases accompanied by ocular spatial structural abnormalities.
Read the detailed description
In patients with complex cataracts, lens opacities are often accompanied by spatial structural disorders or abnormalities involving both the lens itself and its surrounding tissues, including the anterior and posterior ocular segments. Due to the lack of precise preoperative assessment tools and standardized surgical protocols, these cases present higher surgical complexity and technical difficulty, often resulting in suboptimal outcomes. Therefore, preoperative objective quantitative analysis of the three-dimensional morphology and spatial relationships of the anterior segment, posterior segment, and the entire globe is crucial for surgical planning, prevention of complications, and postoperative visual recovery.
This study employs a retrospective research design. Using multimodal imaging systems-including anterior segment swept-source optical coherence tomography (SS-OCT), CT, B-scan ultrasound, and ultrasound biomicroscopy (UBM)-we aim to explore methods for full-eye three-dimensional reconstruction. The goal is to construct a comprehensive 3D ocular model that includes the cornea, anterior chamber, iris, angle, lens, vitreous cavity, retina, and related fundus structures.
This model will be used to comprehensively analyze morphological and spatial alterations in lens diseases associated with ocular spatial abnormalities, providing an objective quantitative description. Furthermore, the study will validate the effectiveness of this full 3D ocular model in clinical diagnosis, surgical planning, and prognosis assessment for this broad category of conditions. Ultimately, it seeks to establish objective, quantitative reference standards for the precise diagnosis and treatment of lens diseases complicated by ocular spatial structural disorders.
- Conditions
- Lens Diseases
- Medical subject headings
- Lens Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Toward 3D Modeling for Lens Disorders Associated with Congenital Anomalies | Part I: Exploration and research on full three-dimensional modeling in the diagnosis and treatment of lens diseases with congenital developmental anomaliesa | |
| Toward 3D Modeling for Reconstructive Management of Ocular Trauma | Part II: Exploration and research on full three-dimensional modeling for the reconstruction and treatment of ocular trauma | |
| Toward 3D Modeling for IOL Spatial Positioning | Part III: Exploration and research on full three-dimensional modeling for the spatial positioning of pseudophakic eyes | |
| Toward 3D Modeling for Cataracts with Iris/Pupillary Abnormalities | Part IV: Exploration and research on full three-dimensional modeling for cataract patients with iris or pupillary abnormalities | |
| Toward 3D Modeling for Cataracts with Posterior Segment Diseases | Part V: Exploration and research on full three-dimensional modeling for the management and treatment of cataract patients with posterior segment diseases | |
| Normal Control Group | Exploration and research on full three-dimensional modeling for individuals with no significant structural ocular diseases served as the normal control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anterior Segment SS-OCT Quantitative Results
Quantification of the anterior segment SS-OCT imaging results
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Computed tomography
Quantification of ocular CT imaging results
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
B-scan ultrasonography
Quantification of the B-ultrasound imaging results of the eyes
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Ultrasound Biomicroscope
Quantification of the results of ocular UBM examination
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Secondary outcomes (2)
IOL tilt decentration ELP
Using SS-OCT to record the effective position of the IOL.
Measured: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Surgical Record
Intraoperative documentation included surgical procedures, irrigation system parameters, phacoemulsification energy, and other relevant information.
Measured: During the operation
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 start1 Jan 2020
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (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.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- 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
- NCT07321769
- Sponsor's protocol ID
- 2025-1229
- Status last verified
- Nov 2025
- First submitted
- 7 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Full 3D Eye Modeling in the Diagnosis and Treatment of Lens Diseases With Eye Structures Disorders
- ClinicalTrials.gov ID
- NCT07321769
- Acronym / sponsor ID
- 2025-1229
- Conditions
- Lens Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (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.
In patients with complex cataracts, spatial abnormalities in the lens and its surrounding tissues-including both the anterior and posterior ocular segments-are often present. Due to the lack of precise preoperative assessment tools and standardized surgical protocols, these cases are associated with increased surgical complexity and difficulty, often leading to suboptimal visual outcomes. Therefore, this study explores a three-dimensional reconstruction method for the anterior segment based on swept-source optical coherence tomography (SS-OCT). By integrating imaging data from CT, B-scan ultrasound, and ultrasound biomicroscopy (UBM), a full three-dimensional model of the eye is constructed to enable objective and quantitative evaluation of its entire structure. This approach aims to provide valuable reference for surgical planning and prognostic assessment in lens diseases accompanied by ocular spatial structural abnormalities.
Detailed description
In patients with complex cataracts, lens opacities are often accompanied by spatial structural disorders or abnormalities involving both the lens itself and its surrounding tissues, including the anterior and posterior ocular segments. Due to the lack of precise preoperative assessment tools and standardized surgical protocols, these cases present higher surgical complexity and technical difficulty, often resulting in suboptimal outcomes. Therefore, preoperative objective quantitative analysis of the three-dimensional morphology and spatial relationships of the anterior segment, posterior segment, and the entire globe is crucial for surgical planning, prevention of complications, and postoperative visual recovery.
This study employs a retrospective research design. Using multimodal imaging systems-including anterior segment swept-source optical coherence tomography (SS-OCT), CT, B-scan ultrasound, and ultrasound biomicroscopy (UBM)-we aim to explore methods for full-eye three-dimensional reconstruction. The goal is to construct a comprehensive 3D ocular model that includes the cornea, anterior chamber, iris, angle, lens, vitreous cavity, retina, and related fundus structures.
This model will be used to comprehensively analyze morphological and spatial alterations in lens diseases associated with ocular spatial abnormalities, providing an objective quantitative description. Furthermore, the study will validate the effectiveness of this full 3D ocular model in clinical diagnosis, surgical planning, and prognosis assessment for this broad category of conditions. Ultimately, it seeks to establish objective, quantitative reference standards for the precise diagnosis and treatment of lens diseases complicated by ocular spatial structural disorders.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Toward 3D Modeling for Lens Disorders Associated with Congenital Anomalies | – | –Part I: Exploration and research on full three-dimensional modeling in the diagnosis and treatment of lens diseases with congenital developmental anomaliesa |
| Toward 3D Modeling for Reconstructive Management of Ocular Trauma | – | –Part II: Exploration and research on full three-dimensional modeling for the reconstruction and treatment of ocular trauma |
| Toward 3D Modeling for IOL Spatial Positioning | – | –Part III: Exploration and research on full three-dimensional modeling for the spatial positioning of pseudophakic eyes |
| Toward 3D Modeling for Cataracts with Iris/Pupillary Abnormalities | – | –Part IV: Exploration and research on full three-dimensional modeling for cataract patients with iris or pupillary abnormalities |
| Toward 3D Modeling for Cataracts with Posterior Segment Diseases | – | –Part V: Exploration and research on full three-dimensional modeling for the management and treatment of cataract patients with posterior segment diseases |
| Normal Control Group | – | –Exploration and research on full three-dimensional modeling for individuals with no significant structural ocular diseases served as the normal control group. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The data for this project was collected from patients who visited the Second Affiliated Hospital, School of Medicine, Zhejiang University from January 1, 2020 to December 31, 2025.
Key inclusion criteria (10 listed)
- Part I：Toward 3D Modeling for Lens Disorders Associated with Congenital Anomalies
- 1) Diagnosed with lens disorders such as lens subluxation or deformity via imaging (slit-lamp, UBM) or clinical examination, combined with conditions such as megalocornea, microcornea, nanophthalmos, keratoconus, or iris coloboma; 2) Presence of imageable ocular structures; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, and anterior segment SS-OCT.
- Part II: Toward 3D Modeling for Reconstructive Management of Ocular Trauma 1) Diagnosed with previous or stabilized corneal trauma, traumatic cataract, or iris injury, with or without associated vitreous traction or retinal damage; 2) Patients with open globe injuries that have been managed, with closed wounds and no endophthalmitis; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, anterior segment SS-OCT, and CT.
- Part III:Toward 3D Modeling for IOL Spatial Positioning 1) Patients who have undergone cataract extraction with intraocular lens (IOL) implantation (in-the-bag or scleral-fixated); 2) Stable IOL position post-implantation with clear documentation of IOL parameters; 3) Able to cooperate with and complete relevant examinations including B-scan ultrasound, UBM, and anterior segment SS-OCT.
- Part IV: Toward 3D Modeling for Cataracts with Iris/Pupillary Abnormalities
Key exclusion criteria (11 listed)
- Part I: Toward 3D Modeling for Lens Disorders Associated with Congenital Anomalies
- 1) Concurrent open globe injury or severe ocular deformity; 2) Excessive corneal opacity or severe edema resulting in inadequate image quality; 3) Severe dry eye or tear film abnormalities affecting imaging;4) Severe ocular structural deformity preventing effective 3D model reconstruction; 5) Severe systemic disease precluding tolerance of the examination; 6) Contraindications to B-scan ultrasound or UBM, conditions impairing imaging, or allergy to coupling gel.
- Part II: Toward 3D Modeling for Reconstructive Management of Ocular Trauma
- 1) Unmanaged open globe injury or severe ocular deformity; 2) Severe systemic disease precluding tolerance of the examination; 3) Contraindications to CT imaging (e.g., metallic implants in the head/face region, pregnancy, lactation) or history of contrast medium allergy/adverse reactions.
- Part III: Toward 3D Modeling for IOL Spatial Positioning
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anterior Segment SS-OCT Quantitative Results
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Quantification of the anterior segment SS-OCT imaging results
Computed tomography
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Quantification of ocular CT imaging results
B-scan ultrasonography
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Quantification of the B-ultrasound imaging results of the eyes
Ultrasound Biomicroscope
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Quantification of the results of ocular UBM examination
2 secondary outcomes
IOL tilt decentration ELP
Time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months
Surgical Record
Time frame: During the operation
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: Undecided
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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?
An observational study of 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 10 inclusion and 11 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?
Anterior Segment SS-OCT Quantitative Results (time frame: Preoperatively, and postoperatively at 1 week, 1 month, and 3 months). The study lists 4 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.