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Recruiting NCT06687356

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

No phase Interventional Lens Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery with Intraoperative Optical Coherence Tomography application, Conventional surgery.
Who it may be relevant to
Registry conditions: Lens Diseases. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Detailed description

In the eyes of patients with lens diseases, there are often some special anterior segment changes, including ectopia lentis, abnormal lens morphology, and rupture of the lens capsule. These changes can be caused by ocular trauma, congenital anomalies, or be secondary to other ocular diseases and systemic diseases. Accurately assessing and dealing with these anterior segment changes can better guide the operation details during surgery and make reasonable plans for possible intraoperative and postoperative complications. This study is based on intraoperative optical coherence tomography technique, 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.

Interventions

  • Procedure Surgery with Intraoperative Optical Coherence Tomography application
    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.
  • Procedure Conventional surgery
    Conventional lens surgery, without the application of intraoperative optical coherence tomography technique.

Primary outcome measures

  • Successful implantation rate of intraocular lens [Time frame: through study completion, an average of 1 year]
  • Intraocular lens position after implantation [Time frame: 1day, 1 week and 1 month postoperation]
Secondary outcome measures (2)
  • Postoperative corneal incision closure status [Time frame: 1day, 1 week postoperation]
  • Visual function [Time frame: 1day, 1 week, 1 month, 3month postoperation]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Single blind
Primary purpose
Treatment

Study locations

China · 2 centers
  • Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
  • Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou

Identifiers

NCT: NCT06687356 · 2024-0993

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗