Clinical trial NCT06687356: Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases
Official title: Study on the Application of Intraoperative Optical Coherence Tomography Technique in the Diagnosis and Treatment of Lens Diseases
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Lens Diseases
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2024-11-13
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

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.

Primary outcomes:
measure: Successful implantation rate of intraocular lens
timeFrame: through study completion, an average of 1 year
measure: Intraocular lens position after implantation
timeFrame: 1day, 1 week and 1 month postoperation
Secondary outcomes:
measure: Postoperative corneal incision closure status
timeFrame: 1day, 1 week postoperation
measure: Visual function
timeFrame: 1day, 1 week, 1 month, 3month postoperation
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Second Affiliated Hospital, Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References: