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:
NCT07321769
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.
Healthy Volunteers:
True
Sex:
ALL
Study:
NCT07321769
Study Brief:
Protocol Section:
NCT07321769