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

November 25, 2024 updated by: Qing Feng, Changzhou No.2 People's Hospital
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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

9

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Changzhou, Jiangsu, China, 213100
        • The Second People's Hospital of Changzhou

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients with dislocated intravitreal lens nuclei who underwent 23G pars plana vitrectomy (PPV) and 25G needle-assisted phacoemulsification and without surgical contraindications exist.

Description

Inclusion Criteria:

Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent

Exclusion Criteria:

Surgical contraindications

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperatively and postoperatively for at least 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: Preoperatively and postoperatively for at least 6 months.
Intraocular pressure was measured with noncontact tonometer.
Preoperatively and postoperatively for at least 6 months.
Corneal endothelial cell count
Time Frame: Preoperatively and postoperatively for at least 6 months.
Corneal endothelial cell count was measured with specular microscope.
Preoperatively and postoperatively for at least 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Changzhou No.2 People's Hospital

Investigators

  • Study Director: Xincheng Sun, Changzhou No.2 People's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2022

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

September 1, 2024

Study Registration Dates

First Submitted

November 21, 2024

First Submitted That Met QC Criteria

November 25, 2024

First Posted (Actual)

November 29, 2024

Study Record Updates

Last Update Posted (Actual)

November 29, 2024

Last Update Submitted That Met QC Criteria

November 25, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213000

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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