NCT06709378

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2022

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 21, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 29, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2.2 years

First QC Date

November 21, 2024

Last Update Submit

November 25, 2024

Conditions

Dislocated LensPars Plana VitrectomyPhacoemulsificationNeedle

Outcome Measures

Primary Outcomes (1)

  • Best corrected visual acuity

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

    Preoperatively and postoperatively for at least 6 months.

Secondary Outcomes (2)

  • Intraocular pressure

    Preoperatively and postoperatively for at least 6 months.

  • Corneal endothelial cell count

    Preoperatively and postoperatively for at least 6 months.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent

You may not qualify if:

  • Surgical contraindications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

the Second People's Hospital of Changzhou

Changzhou, Jiangsu, 213100, China

Location

MeSH Terms

Conditions

Lens Subluxation

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Study Officials

  • Xincheng Sun

    Changzhou No.2 People's Hospital

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2024

First Posted

November 29, 2024

Study Start

July 1, 2022

Primary Completion

September 1, 2024

Study Completion

September 1, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)