Clinical trial Recruiting at 1 site Observational

3D eye modeling to guide diagnosis and treatment of lens problems

Official title: Full 3D Eye Modeling in the Diagnosis and Treatment of Lens Diseases With Eye Structures Disorders

Run by Second Affiliated Hospital, Zhejiang University, School of Medicine · NCT07321769 · Data updated 2026-11-12

This project will try a full 3D eye model made from multiple scans to help surgeons plan treatment for people with complex lens problems such as dislocated, traumatic, or malformed lenses.

More Lens Diseases trials

Quick facts

Study typeObservational
SexAll
Enrollment1200 (estimated)
SponsorSecond Affiliated Hospital, Zhejiang University, School of Medicine
Academic / other
Locations1 site (Hangzhou, Zhejiang)
StatusRecruiting
StartedJanuary 1, 2020
Main results expectedDecember 31, 2025
Study endsDecember 31, 2025
Registry record updatedJanuary 7, 2026
Trial IDNCT07321769 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are people with complex lens disorders (for example, lens subluxation, deformity, or traumatic cataract) and associated ocular structural abnormalities who can undergo multimodal imaging and attend the Zhejiang University hospital.

Probably not a fit

Patients unlikely to benefit include those whose eyes cannot be adequately imaged (for example, active endophthalmitis or dense media opacities), those with routine uncomplicated cataracts, or those unable to travel to the study site.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This retrospective project combines anterior-segment swept-source OCT with CT, B‑scan ultrasound, and ultrasound biomicroscopy to build a full three-dimensional model of the globe, including cornea, anterior chamber, iris, lens, vitreous, retina, and fundus structures. The multimodal image fusion provides objective, quantitative descriptions of morphological and spatial relationships in eyes with lens disorders associated with congenital anomalies or prior trauma. Investigators will use the model to inform preoperative planning, anticipate surgical difficulty, and support prognostic evaluation. The work focuses on patients with imageable ocular structures who can complete the required imaging at the single tertiary center.

Why it matters

Potential benefit: If successful, the model could improve surgical planning, reduce intraoperative complications, and lead to better visual outcomes for patients with complex lens disorders.

How similar studies have gone: Individual imaging modalities such as OCT, CT, B‑scan, and UBM are well established, but full-eye multimodal 3D reconstruction for lens surgery planning is relatively novel with limited prior reports.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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

  1. 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.
* 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

  1. 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.

Exclusion Criteria:

* 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.
* 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.

Where it's running

  • Second Affiliated Hospital, Zhejiang University School of Medicine,
    Hangzhou, Zhejiang, China
    Recruiting

Study contacts

  • Principal investigator: Wen Xu, Phd — Second Affiliated Hospital, Zhejiang University, School of Medicine
  • Study coordinator: Wen Xu, Phd
  • Email: xuwen2003@zju.edu.cn
  • Phone: +86-13858185223

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.