The Innovative Appliance of Cohesive Viscoelastic During Pars Plana Vitrectomy in Complicated Ocular Trauma

NCT ID: NCT07038668

Last Updated: 2025-08-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

420 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ocular Trauma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed Group

Using of viscoelastic during the operation

Intervention Type PROCEDURE

Using of viscoelastic during the operation

Non-Exposed Group

No using of viscoelastic during the operation

Intervention Type PROCEDURE

No using of viscoelastic during the operation

Interventions

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Using of viscoelastic during the operation

Using of viscoelastic during the operation

Intervention Type PROCEDURE

No using of viscoelastic during the operation

No using of viscoelastic during the operation

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Severe traumatic ocular injury (ocular trauma score, OTS=1 or 2)
* PVR retinal detachment (Stage D2 or D3)

Exclusion Criteria

* Visual acuity below the base line before injury
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Xueying Zhongliu

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Central Contacts

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Liuxueying Zhong, Dr.

Role: CONTACT

15099954411

Other Identifiers

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2025KYPJ043

Identifier Type: -

Identifier Source: org_study_id

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