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Clinical trial of vitreous substitute for intraocular implantation

Clinical trial of vitreous substitute for intraocular implantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300068124
Enrollment
Unknown
Registered
2023-02-08
Start date
2023-02-15
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

Retina and vitreous disease

Interventions

intervention group:Novel vitreous substitutes for intraocular implantation

Sponsors

West China Hospital, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Be able to understand and sign the informed consent form. 2) Chinese adults over the age of 18, diagnosed as having no light perception in the included eyes; 3) Able to complete all the postoperative follow-up content required in the protocol; 3) Those who have undergone corneal clear surgery on anterior segment photography are evaluated to be able to perform vitrectomy; 4) Electrophysiological examination VEP showed no waves in the enrolled eyes; 5) The best corrected visual acuity of the contralateral eye is 0.5 and above; 6) There is an iris or a lens or an intraocular lens separating the anterior and posterior chambers

Exclusion criteria

Exclusion criteria: 1) Past or present suffering from ocular or systemic immune system diseases such as uveitis and retinal vasculitis; 2) Corneal endothelial cell count is less than 2000 cells/mm2; 3) Clinically significant corneal disease (epithelial, stromal and/or endothelium) that, according to the investigator's medical opinion, adversely affects visual outcomes. These ocular diseases include, but are not limited to, significant corneal scarring (including Salzmann nodular keratosis), active or inactive keratitis with impaired corneal refractive power, keratoconjunctivitis sicca with impaired visual function, Active keratouveitis, endothelial corneal dystrophy (Fuch's and non-punctate), keratoconus, etc.; 4) Current or planned pregnant or lactating female patients; 5) Any subject who is currently involved in another drug or device study that may confound the results of this study; 6) According to the investigator's medical opinion, any other ocular or systemic comorbidities may confound the results of this study or prevent completion of the study evaluation or increase the risk to the subject; 7) Patients with hypertension or diabetic retinopathy who are taking hypoglycemic or hypotensive drugs; 8) Those with severe cardiovascular and cerebrovascular diseases, malignant tumors, mental disorders and incapacity of autonomous behavior, etc., are considered inappropriate by the researchers.

Design outcomes

Secondary

MeasureTime frame
optical coherence tomography(OCT);optical coherence tomography angiography(OCTA);undus angiography;Slit-lamp examination;B-scan;endothelial cells;Fundus photography;

Primary

MeasureTime frame
Best corrected visual acuity(BCVA);Intraocular pressure;

Countries

China

Contacts

Public ContactMing Zhang

The Department of Opthlamology,West China Hospital of Sichuan University

zhangmingscu@126.com18980601020

Outcome results

None listed

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