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

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

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.

Quick facts

• Study type: Observational
• Enrollment: 1200 (estimated)
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07321769 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital, Zhejiang University School of Medicine, — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Principal investigator: Wen Xu, Phd — Second Affiliated Hospital, School of Medicine, Zhejiang University
• Study coordinator: Wen Xu, Phd

Conditions: Lens Diseases