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

NCT07038668 | Not Yet Recruiting DMC

• 1 other identifier: 2025KYPJ043
• Study Type: observational
• Target: 420
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (2)

• Best Corrected Visual Acuity(BCVA)

  Best Corrected Visual Acuity

  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.

  Post operation till the end of follow up in 3 months

Study Arms (2)

Exposed Group

Procedure: Using of viscoelastic during the operation

Non-Exposed Group

Procedure: No using of viscoelastic during the operation

Interventions

Using of viscoelastic during the operation PROCEDURE

Using of viscoelastic during the operation

Exposed Group

No using of viscoelastic during the operation PROCEDURE

No using of viscoelastic during the operation

Non-Exposed Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from the outpatient department of Zhongshan Ophthalmic Center

You may qualify if:

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

You may not qualify if:

• Visual acuity below the base line before injury

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

Central Study Contacts

Liuxueying Zhong, Dr.

CONTACT

15099954411; zhongliuxueying@gzzoc.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 18, 2025
• First Posted: June 26, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 12, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL