Effectiveness and Safety of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus

Completed

• Conditions: Dislocated Lens; Pars Plana Vitrectomy; Phacoemulsification; Needle

• Registration Number: NCT06709378
• Lead Sponsor: Changzhou No.2 People's Hospital

Brief Summary

The goal of this observational study is to learn about the effects of 25-gauge (G) needle-assisted phacoemulsification to remove dislocated intravitreal lens nuclei.

Detailed Description

Patients with dislocated intravitreal lens nuclei who underwent 23G pars plana vitrectomy (PPV) and 25G needle-assisted phacoemulsification between July 2022 and September 2024 were included. Primary outcomes included best-corrected visual acuity (BCVA) and intraocular pressure (IOP). Secondary outcomes included corneal endothelial cell count (CECC) and the incidence of intraoperative and postoperative complications. These outcomes were statistically analyzed both preoperatively and postoperatively. A minimum follow-up of 6 months was completed for all eyes.

Study Timeline

• Study Start: 2022-07-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-01
• Status Verified: 2024-11
• Study First Submitted: 2024-11-21
• Study First Submitted QC: 2024-11-25
• Last Update Submitted: 2024-11-25
• Study First Posted: 2024-11-28
• Last Update Posted: 2024-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent

Exclusion Criteria

Surgical contraindications

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity	Preoperatively and postoperatively for at least 6 months.	Best corrected visual acuity was measured with logarithmic visual acuity chart.

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	Preoperatively and postoperatively for at least 6 months.	Intraocular pressure was measured with noncontact tonometer.
Corneal endothelial cell count	Preoperatively and postoperatively for at least 6 months.	Corneal endothelial cell count was measured with specular microscope.

Trial Locations

Locations (1)

the Second People's Hospital of Changzhou; 🇨🇳 Changzhou, Jiangsu, China