Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases

NCT06687356 | Recruiting

• 1 other identifier: 2024-0993
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 2

Brief Summary

Accurately assessing and dealing with anterior segment changes in the eyes of patients with lens diseases can better guide the operation details during surgery and make reasonable plans for possible intraoperative and postoperative complications. Applying the intraoperative optical coherence tomography technique, this study analyzes the correlation between preoperative, intraoperative anterior segment structural changes and postoperative surgical effects in patients with lens diseases, and evaluates the clinical benefits of intraoperative optical coherence tomography technique in lens surgery. This study is intended to further improve the diagnosis and treatment quality of clinical lens diseases.

Conditions

Lens Diseases

Outcome Measures

Primary Outcomes (2)

• Successful implantation rate of intraocular lens

  Implantation rate of intraocular lens after surgery.

  through study completion, an average of 1 year

• Intraocular lens position after implantation

  The location of intraocular lens after surgery, observed through slit - lamp and anterior segment optical coherence tomography.

  1day, 1 week and 1 month postoperation

Secondary Outcomes (2)

• Postoperative corneal incision closure status

  1day, 1 week postoperation

• Visual function

  1day, 1 week, 1 month, 3month postoperation

Study Arms (2)

Traditional surgery

ACTIVE COMPARATOR

Without using the intraoperative optical coherence tomography technique during surgery.

Procedure: Conventional surgery

Surgery with intraoperative optical coherence tomography technique

EXPERIMENTAL

Applying the intraoperative optical coherence tomography technique during surgery.

Procedure: Surgery with Intraoperative Optical Coherence Tomography application

Interventions

Surgery with Intraoperative Optical Coherence Tomography application PROCEDURE

Surgery with the application of intraoperative optical coherence tomography technique. 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.

Also known as: Surgery with Intraoperative OCT application

Surgery with intraoperative optical coherence tomography technique

Conventional surgery PROCEDURE

Conventional lens surgery, without the application of intraoperative optical coherence tomography technique.

Traditional surgery

Eligibility Criteria

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

You may qualify if:

• Patients aged over 18 years old, with lens opacity or abnormal position, and other conditions meeting the surgical indications, needing lens surgery treatment, with or without anterior segment structural changes.

You may not qualify if:

• Combined with other eye diseases that seriously affect visual prognosis, serious systemic diseases and other conventional contraindications for lens surgery.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (2)

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

NOT YET RECRUITING

Second Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Lens Diseases

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Eye Diseases

Central Study Contacts

Wen Xu, PHD

CONTACT

13858185223; xuwen2003@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 8, 2024
• First Posted: November 13, 2024
• Study Start: November 27, 2024
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: May 22, 2025

Record last verified: 2025-05

Locations

CN (2)