Multicenter Study on the Use of Intraoperative Optical Coherence Tomography in the Diagnosis and Management of Lens Diseases
| Registry | NCT07741370 |
|---|---|
| Status | Active not recruiting |
| Study type | Observational |
| Enrollment | 1200 (Estimated) |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine (Other); collaborators: Chinese PLA General Hospital, Xi'an People's Hospital (Xi'an Fourth Hospital), Fourth Affiliated Hospital of Xinjiang Medical University, Shandong Provincial Hospital, People's Hospital of Ningxia Hui Autonomous Region |
| Conditions | Lens Diseases, Cataract, Age-related Cataract, Complicated Cataract, Lens Subluxation |
| Interventions | Intraoperative Optical Coherence Tomography (Device) |
| Dates | start 2024-03-01, primary completion 2026-03-01, completion 2034-12-31 (estimated), first posted 2026-08-03, last updated 2026-08-05 |
| Locations | 1 site in China |
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All trials for Lens Diseases All trials for Cataract All trials of Intraoperative Optical Coherence Tomography
This multicenter retrospective study will collect clinical data to investigate the associations between preoperative and intraoperative anterior segment structural changes and postoperative surgical outcomes in patients with lens disorders, and to evaluate the clinical benefits of intraoperative optical coherence tomography (iOCT) in lens surgery, with the aim of improving the diagnosis and treatment of lens-related diseases.
Lens disorders, particularly cataract, are a leading cause of blindness worldwide and substantially impair quality of life. Surgery remains the most effective treatment, but pre-existing abnormalities of the lens and adjacent ocular structures, together with unexpected intraoperative events, may increase surgical complexity and affect outcomes. Accurate assessment of anterior segment structures is therefore essential, as abnormalities caused by trauma, congenital disorders, ocular diseases, or systemic conditions may involve the lens, capsule, cornea, iris, or anterior chamber angle. Even during routine phacoemulsification, variations in irrigation pressure, anterior chamber depth, capsular bag integrity, capsular expansion, and residual cortex may influence surgical safety, IOL centration, and postoperative refractive stability. Because some abnormalities cannot be reliably detected preoperatively, intraoperative optical coherence tomography (iOCT) may provide real-time structural information and support surgical decision-making. However, evidence regarding its effects on surgical strategy, visual outcomes, refractive stability, and complications remains limited. This multicenter retrospective study will assess the associations between preoperative and intraoperative anterior segment changes and postoperative outcomes, and evaluate the clinical value of iOCT in lens surgery.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Conventional Microscopy Cohort | Patients who underwent lens surgery using conventional surgical microscopy without intraoperative OCT. | ||
| Intraoperative OCT-Assisted Surgery Cohort | Device: Intraoperative Optical Coherence Tomography | Patients who underwent lens surgery using conventional surgical microscopy with intraoperative OCT assistance. |
Sex: All, ages: 18 Years to any
Inclusion Criteria: * Aged 18 years or older. * Presence of lens opacity or abnormal lens position. * Visual impairment affecting activities of daily living. * Met the indications for lens surgery. * Underwent lens surgery. Exclusion Criteria: * Active intraocular inflammation. * Uncontrolled systemic disease, use of medications that could significantly affect surgery, or other standard contraindications to lens surgery. * Incomplete or unreliable key preoperative examination data, including ocular biometry. * Inadequate image quality due to poor fixation or other causes, rendering the images unsuitable for analysis. * Incomplete intraoperative OCT recordings, such as interrupted recording or severe image freezing, affecting data evaluation. * Other psychological or physical conditions that might interfere with study participation.
| Facility | City | Country | Status |
|---|---|---|---|
| Second Affiliated Hospital, Zhejiang University School of Medicine | Hangzhou, Zhejiang | China |