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OpenTrials
Completed

NCT Number: NCT06709378

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

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.

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Key information

Conditions

Dislocated Lens Eye Diseases Lens Diseases Lens Subluxation Needle Pars Plana Vitrectomy Phacoemulsification

Sex eligibility

All sexes

Study type

Observational

Primary location

the Second People's Hospital of Changzhou

Changzhou, Jiangsu, 213100, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent

Exclusion criteria

Surgical contraindications

Treatment and study plan

Primary outcomes

  1. Best corrected visual acuity

    Time frame: Preoperatively and postoperatively for at least 6 months.

    Best corrected visual acuity was measured with logarithmic visual acuity chart.

Secondary outcomes

  1. Intraocular pressure

    Time frame: Preoperatively and postoperatively for at least 6 months.

    Intraocular pressure was measured with noncontact tonometer.

  2. Corneal endothelial cell count

    Time frame: Preoperatively and postoperatively for at least 6 months.

    Corneal endothelial cell count was measured with specular microscope.

Sponsors and collaborators

Lead sponsor

Changzhou No.2 People's Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Nov 29, 2024
Registry last updated
Nov 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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