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NCT Number: NCT07741370

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 18 years or older with lens opacity or abnormal lens position, whose visual function was insufficient for daily activities, who met the indications for surgery, and who had undergone lens surgery.

Exclusion criteria

  • 1. Patients aged 18 years or older with lens opacity or abnormal lens position, whose visual function was insufficient for daily activities, who met the indications for surgery, and who had undergone lens surgery.
  • Active intraocular inflammation. 3. 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.

6.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.

Treatment and study plan

Intraoperative Optical Coherence Tomography

Device

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.

Primary outcomes

  1. Concordance Rate Between Preoperative and Intraoperative Diagnoses

    Time frame: From 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 outcomes

  1. Intraocular Lens Tilt Angle

    Time frame: After 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.

  2. Incidence of Intraoperative Complications

    Time frame: From the start to the end of surgery.

    Intraoperative complications are identified from operative records and intraoperative imaging. The incidence of each complication is calculated.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Collaborators

  • Chinese PLA General Hospital
  • Fourth Affiliated Hospital of Xinjiang Medical University
  • People's Hospital of Ningxia Hui Autonomous Region
  • Shandong Provincial Hospital
  • Xi'an People's Hospital (Xi'an Fourth Hospital)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2034
First posted
Aug 3, 2026
Registry last updated
Aug 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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