Ocular TraumaNCT07038668
The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma
An observational study of Ocular Trauma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial summary
Viscoelastic is a powerful tool in pars plana vitrectomy(PPV) surgery relative to perfluorocarbon liquid because it has the properties to dilate and engorge the retina and restore the detached retina to its original position. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ocular Trauma
- What is being tested?
- Using of viscoelastic during the operation and No using of viscoelastic during the operation
- Type of treatment
- Surgery or procedure
- How many people
- 420 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Study population will be selected from the outpatient department of Zhongshan Ophthalmic Center
Who may be able to join
- Severe traumatic ocular injury (ocular trauma score, OTS=1 or 2)
- PVR retinal detachment (Stage D2 or D3)
Who cannot join
- Visual acuity below the base line before injury
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Viscoelastic is a powerful tool in pars plana vitrectomy(PPV) surgery relative to perfluorocarbon liquid because it has the properties to dilate and engorge the retina and restore the detached retina to its original position. We intend to explore whether the use of viscoelastic to assist PPV surgery can help improve surgical efficiency, reduce tissue damage, and improve the outcomes of the patients.
- Conditions
- Ocular Trauma
- Being tested
- Using of viscoelastic during the operation, No using of viscoelastic during the operation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using of viscoelastic during the operationProcedure or surgery
Using of viscoelastic during the operation
No using of viscoelastic during the operationProcedure or surgery
No using of viscoelastic during the operation
| Study group | Role | What they receive |
|---|---|---|
| Exposed Group | Not described Receives: Procedure: Using of viscoelastic during the operation | |
| Non-Exposed Group | Not described Receives: Procedure: No using of viscoelastic during the operation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best Corrected Visual Acuity(BCVA)
Best Corrected Visual Acuity
Measured: From enrollment to the end of follow up in 3 months
Reattachment of Retina
Check through ultrasound, optical coherence tomography(OCT) to see if retina is reattached.
Measured: Post operation till the end of follow up in 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2025
- Study start1 Sep 2025 (estimated)
- Primary completion1 Sep 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ocular TraumaStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xueying Zhongliu, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07038668
- Sponsor's protocol ID
- 2025KYPJ043
- Status last verified
- Aug 2025
- First submitted
- 18 Jun 2025
- Last updated
- 12 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma
- ClinicalTrials.gov ID
- NCT07038668
- Acronym / sponsor ID
- 2025KYPJ043
- Conditions
- Ocular Trauma
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 26 Jun 2025 (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.
Viscoelastic is a powerful tool in pars plana vitrectomy(PPV) surgery relative to perfluorocarbon liquid because it has the properties to dilate and engorge the retina and restore the detached retina to its original position. We intend to explore whether the use of viscoelastic to assist PPV surgery can help improve surgical efficiency, reduce tissue damage, and improve the outcomes of the patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed Group | – | Procedure: Using of viscoelastic during the operation |
| Non-Exposed Group | – | Procedure: No using of viscoelastic during the operation |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population will be selected from the outpatient department of Zhongshan Ophthalmic Center
Key inclusion criteria (2 listed)
- Severe traumatic ocular injury (ocular trauma score, OTS=1 or 2)
- PVR retinal detachment (Stage D2 or D3)
Key exclusion criteria (1 listed)
- Visual acuity below the base line before injury
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using of viscoelastic during the operationUsing of viscoelastic during the operation | Procedure or surgery | Exposed Group |
| No using of viscoelastic during the operationNo using of viscoelastic during the operation | Procedure or surgery | Non-Exposed Group |
Primary outcome
Best Corrected Visual Acuity(BCVA)
Time frame: From enrollment to the end of follow up in 3 months
Best Corrected Visual Acuity
Reattachment of Retina
Time frame: Post operation till the end of follow up in 3 months
Check through ultrasound, optical coherence tomography(OCT) to see if retina is reattached.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2025.
- Individual participant dataSharing planned: Yes
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Ocular Trauma, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
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 2 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: opening soon, as of the sponsor's last update on 12 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Liuxueying Zhong, Dr. (15099954411, zhongliuxueying@gzzoc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity(BCVA) (time frame: From enrollment to the end of follow up in 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2025.