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

NCT07741370 | Active Not Recruiting

• 1 other identifier: 2026-0218
• Study Type: observational
• Target: 1,200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Intraoperative Optical Coherence Tomography; Lens Diseases

Outcome Measures

Primary Outcomes (1)

• Concordance Rate Between Preoperative and Intraoperative Diagnoses

  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.

  From completion of the preoperative examinations through the end of surgery; diagnostic concordance is assessed after surgery.

Secondary Outcomes (2)

• Intraocular Lens Tilt Angle

  After intraocular lens implantation and at the end of surgery.

• Incidence of Intraoperative Complications

  From the start to the end of surgery.

Study Arms (2)

Conventional Microscopy Cohort

Patients who underwent lens surgery using conventional surgical microscopy without intraoperative OCT.

Intraoperative OCT-Assisted Surgery Cohort

Patients who underwent lens surgery using conventional surgical microscopy with intraoperative OCT assistance.

Device: Intraoperative Optical Coherence Tomography

Interventions

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.

Intraoperative OCT-Assisted Surgery Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 18 years or older who underwent lens surgery for lens opacity or abnormal lens position between March 1, 2024 and March 1, 2026 at the participating hospitals. Eligible surgical eyes will be identified retrospectively from medical records and classified according to whether intraoperative optical coherence tomography was used during surgery.

You may qualify if:

• 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.

You may not qualify if:

• \. 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.
• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• Chinese PLA General Hospital: collaborator
• Xi'an People's Hospital (Xi'an Fourth Hospital): collaborator
• Fourth Affiliated Hospital of Xinjiang Medical University: collaborator
• Shandong Provincial Hospital: collaborator
• People's Hospital of Ningxia Hui Autonomous Region: collaborator

Study Sites (1)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

Location

MeSH Terms

Conditions

Lens Diseases; Cataract; Capsule Opacification; Lens Subluxation

Condition Hierarchy (Ancestors)

Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: August 3, 2026
• Study Start: March 1, 2024
• Primary Completion: March 1, 2026
• Study Completion (Estimated): December 31, 2034
• Last Updated: August 3, 2026

Record last verified: 2026-07

Locations

CN (1)