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Open controlled study of emergency vitrectomy for severe ocular trauma

Open controlled study of emergency vitrectomy for severe ocular trauma

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-OPN-16008799
Enrollment
Unknown
Registered
2016-07-07
Start date
2016-07-01
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

severe ocular trauma

Interventions

2:Within 48 hours of an emergency debridement while intervention vitrectomy
Control:Intervention vitrectomy will be conducted after emergency debridement two weeks

Sponsors

Southwest Hospital, Third Military Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. patients aged 18-75 years (including 18 years of age and 75 years of age) willing to sign an informed consent form; 2. patients within 48 hours after the injury admissions while at least one eye (unilateral) or both eyes due to eye trauma and meet one of the following criteria: 1) rupture (Zone III injuries involving the retina causing retinal incarceration or detachment); 2) penetrating trauma (injuries involving the retina causing retinal incarceration or III District detachment, penetrating injuries); 3) endophthalmitis tendency; 4) Exclude routine emergency vitrectomy (high purity copper and iron, inner organic intraocular foreign body) of other foreign body retinal traction, traumatic detachment; 3. heart and lung liver and kidney function was normal; 4. decreased vision due to eye trauma rather than for other reasons; 5. voluntarily choose vitrectomy patients; 6. can be observed with the adverse events and efficacy; 7. No other eye diseases; 8. normal blood coagulation; 9. female patient was negative pregnancy test; 10. good compliance, to comply with the study or follow-up process.

Exclusion criteria

Exclusion criteria: 1. With the eye / Disease: (1) Study on the Eye hinder research to improve the treatment of diseases associated with vision; (2) the study eye that could affect the interpretation of the results or may result in damage to eyesight or require medical or surgical intervention in the six-month period of treatment of other diseases; (3) the presence of post-impact study eye intraocular pressure control of the entire circumference of the ciliary body detachment; 2. The general condition or treatment; (1) or abnormal clotting function currently being used anticoagulant drugs (such as aspirin) treatment; (2) stroke, coronary heart disease, history of angina and renal dysfunction require dialysis or kidney transplantation, and other unsuitable in a clinical trial of systemic chronic diseases; (3) current or recent use may require general known to the lens, the retina or optic nerve toxic drugs, including chloroquine / hydroxychloroquine, phenothiazines, ethambutol, deferoxamine and tamoxifen, etc.; 3. Compliance (1) can not be observed with the adverse events and efficacy; (2) research or follow-up process can not comply.

Design outcomes

Primary

MeasureTime frame
Eye preservation rate;Reattachment rate;vision;

Secondary

MeasureTime frame
intraocular pressure;

Countries

China

Contacts

Public ContactLiu Yong

Southwest Hospital of Third Military Medical Universit

liuyy99@163.com+86 13983732105

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026