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Multicenter Study on the Use of Intraoperative OCT in the Diagnosis and Management of Lens Diseases

Multicenter Study on the Use of Intraoperative Optical Coherence Tomography in the Diagnosis and Management of Lens Diseases

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07741370
Enrollment
1200
Registered
2026-08-03
Start date
2024-03-01
Completion date
2034-12-31
Last updated
2026-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-related Cataract, Cataract, Complicated Cataract, Lens Diseases, Lens Subluxation

Keywords

Intraoperative Optical Coherence Tomography, Lens Diseases

Brief summary

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.

Detailed description

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.

Interventions

DEVICEIntraoperative Optical Coherence Tomography

Intraoperative optical coherence tomography technique can provide intraocular images and show changes in intraocular structures, assisting in analyzing the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases.

Sponsors

Second Affiliated Hospital, Zhejiang University, School of Medicine
Lead SponsorOTHER
Chinese PLA General Hospital
CollaboratorOTHER
Xi'an People's Hospital (Xi'an Fourth Hospital)
CollaboratorOTHER
Fourth Affiliated Hospital of Xinjiang Medical University
CollaboratorOTHER
Shandong Provincial Hospital
CollaboratorOTHER_GOV
People's Hospital of Ningxia Hui Autonomous Region
CollaboratorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Concordance Rate Between Preoperative and Intraoperative DiagnosesFrom completion of the preoperative examinations through the end of surgery; diagnostic concordance is assessed after surgery.Preoperative diagnoses are determined based on routine ophthalmic examinations. Intraoperative diagnoses are determined based on surgical microscopic observations, intraoperative OCT images, and operative records. Concordance between the preoperative and intraoperative diagnoses is assessed, including whether the intraoperative diagnosis adds to or corrects the preoperative diagnosis.

Secondary

MeasureTime frameDescription
Intraocular Lens Tilt AngleAfter intraocular lens implantation and at the end of surgery.The tilt angle of the implanted intraocular lens is measured on intraoperative OCT images using a standardized image analysis protocol. A predefined ocular-axis reference line is used to calculate the angle between the intraocular lens axis and the reference axis.
Incidence of Intraoperative ComplicationsFrom the start to the end of surgery.Intraoperative complications are identified from operative records and intraoperative imaging. The incidence of each complication is calculated.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 6, 2026