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A study on treatment selection and epidemiology of severe eyeball rupture

A study on treatment selection and epidemiology of severe eyeball rupture

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR1800016090
Enrollment
Unknown
Registered
2018-05-10
Start date
2018-07-01
Completion date
Unknown
Last updated
2018-07-31

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

Conditions

Severe eyeball rupture

Interventions

Group A - foldable capsular vitreous body balloon group:Implant foldable capsular vitreous body balloon
Group B - implantation group of extirpation of the contents of the eye with prosthesis:The contents of the eye were extracted and implanted with the prosthesis

Sponsors

Shenzhen Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Group A - foldable capsular vitreous body balloon group: 1. The best corrected visual acuity was < 0.05; 2. In the case of open eye trauma, the wound is greater than 6 mm but less than 18 mm or has the contents of the eye (severe ciliary body injury and disengagement, lens and vitreous body) come out; 3. In patients with closed eye trauma, severe vitreous hemorrhage (+++ or above) or severe retinal detachment cannot be treated with existing vitreous replacement (unilateral eye): (1) Severe unilateral perforation or perforation of the eye, combined retinal and/or choroid detachment due to retinal rupture, retinal choroid hemorrhage, etc. Or, (2) Severe unilateral ocular rupture resulting in retinal and/or choroid defects;Or, (3) Large posterior sclera laceration of the unilateral eyeball cannot be repaired.Or, (4) The silicone oil can not be removed after long-term filling, and the retinal restoration is incomplete.Or, (5) After two or more retinal detachment surgeries and silicone oil fillings, the retinal detachment occurs again after removal of silicone oil. 4. Patients have good compliance, participate in the test voluntarily, and sign informed consent voluntarily. Group B - implantation group of gouging out the contents of the eye with prosthesis socket: (1) From July, 2016 to July, 2018, due to severe ocular rupture, we conducted enucleation of the contents of the eyes and implantation of the prosthesis in our hospital; (2) Patients have good compliance, participate in the test voluntarily, and sign informed consent voluntarily.

Exclusion criteria

Exclusion criteria: Group A - foldable capsular vitreous body balloon group: 1. Known allergic to silica gel, patients with scar constitution; 2. Endophthalmitis; 3. Uveitis; 4. The intraocular lens is transparent; 5. Proliferative diabetic retinopathy; 6. Corrected visual acuity of the contralateral eye is less than or equal to 0.4; 7. A history of endoscopic surgery in the contralateral eye; 8. Other eye diseases that cannot be controlled; 9. Severe renal and liver damage and/or severe systemic diseases (such as cardiovascular disease, respiratory system, digestive system, nervous system, endocrine system, urogenital system disease, etc.); 10. Women who have been pregnant, are preparing for pregnancy or are lactating; 11. A history of drug abuse or alcoholism; 12. Refusal to participate in the study and failure to implement the study arrangements. Group B - implantation group in which the contents of the eye are extracted and the prosthesis is inserted: Refuse to participate in the study and cannot fulfill the research arrangement; Patients are infants or other conditions that cannot be combined with eye pressure.

Design outcomes

Primary

MeasureTime frame
Visual acuity;Width of palpebral fissure ;Degree of exophthalmus;

Countries

China

Contacts

Public ContactBo Qin

Shenzhen Eye Hospital

qinbozf@126.com+86 13925232186

Outcome results

None listed

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