Dislocated LensNCT06709378
Effectiveness and Safety of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus
An observational study of Dislocated Lens and Pars Plana Vitrectomy, run by Changzhou No.2 People's Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Dislocated Lens, Pars Plana Vitrectomy, Phacoemulsification
- How many people
- 9 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2022to 1 Sep 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent
Who cannot join
- Surgical contraindications
Trial locations and contacts
1 site in 1 country.
China1 site
the Second People's Hospital of Changzhou
Changzhou, Jiangsu, 213100
About this study
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.
Read the 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.
- Conditions
- Dislocated Lens, Pars Plana Vitrectomy, Phacoemulsification, Needle
- Medical subject headings
- Lens Subluxation
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity
Best corrected visual acuity was measured with logarithmic visual acuity chart.
Measured: Preoperatively and postoperatively for at least 6 months.
Secondary outcomes (2)
Intraocular pressure
Intraocular pressure was measured with noncontact tonometer.
Measured: Preoperatively and postoperatively for at least 6 months.
Corneal endothelial cell count
Corneal endothelial cell count was measured with specular microscope.
Measured: Preoperatively and postoperatively for at least 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2024
- Study start1 Jul 2022
- Primary completion1 Sep 2024
- Study completion1 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dislocated LensStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Changzhou No.2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing Feng, Changzhou No.2 People's Hospital
- Investigators
- Xincheng Sun, Study director, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06709378
- Sponsor's protocol ID
- 213000
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 29 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Feng Q, Li Y, Jiang Y, Sun X. Effect of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus. J Ophthalmol. 2026 May 27;2026:8429779. doi: 10.1155/joph/8429779. eCollection 2026.
PubMed 42211675
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Safety of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus
- ClinicalTrials.gov ID
- NCT06709378
- Acronym / sponsor ID
- 213000
- Conditions
- Dislocated Lens, Pars Plana Vitrectomy, Phacoemulsification, Needle
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Changzhou No.2 People's HospitalUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 1 Sep 2024 (actual)
- First posted
- 29 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Retrospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Clinical diagnosis of dislocated intravitreal lens nuclei Signed informed consent
Key exclusion criteria (1 listed)
- Surgical contraindications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
2 secondary outcomes
Intraocular pressure
Time frame: Preoperatively and postoperatively for at least 6 months.
Corneal endothelial cell count
Time frame: Preoperatively and postoperatively for at least 6 months.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2024.
- Derived from this study: PubMed 42211675Feng Q, Li Y, Jiang Y, Sun X. Effect of 25-Gauge Needle-Assisted Phacoemulsification of Dislocated Intravitreal Lens Nucleus. J Ophthalmol. 2026 May 27;2026:8429779. doi: 10.1155/joph/8429779. eCollection 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xincheng Sun study director
Changzhou No.2 People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dislocated Lens and Pars Plana Vitrectomy, run by Changzhou No.2 People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity (time frame: Preoperatively and postoperatively for at least 6 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06709378, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2024.