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A prospective parallel controlled clinical study of posterior pars plana vitrectomy for idiopathic epimacular membrane

A prospective parallel controlled clinical study of posterior pars plana vitrectomy for idiopathic epimacular membrane

Status
Recruiting
Phases
Early Phase 1
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2100046002
Enrollment
Unknown
Registered
2021-05-02
Start date
2021-06-01
Completion date
Unknown
Last updated
2021-12-13

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

Conditions

Idiopathic epimacular membrane

Interventions

Experimental group:Posterior pars plana vitrectomy
Control group:Traditional pars plana vitrectomy

Sponsors

Drum Tower Hospital Affiliated to Medical College of Nanjing University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. Aged >= 50 years; 2. IERM was confirmed by fundus color photography (CFP), frequency domain optical coherence tomography (SD-OCT) and fundus fluorescein angiography (FFA) in our hospital: (1) There were only high reflection bands on the surface of macular retina; (2) Epimacular membrane combined with macular edema showed macular hyperreflexive band with obvious macular neuroepithelial thickening; 3. Indirect ophthalmoscope: there were some IEMR features in the posterior pole macular area, such as gold-leaf reflection, vascular distortion or retinal wrinkle in the arched ring of macular area; 4. With different degrees of vision loss, visual deformation symptoms; 5. Lens opacity <= grade II; 6. The best corrected visual acuity (BCVA) was less than 0.8; 7. Agree to participate in the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: 1. The opacity of refractive interstitium affects fundus examination and treatment; 2. Eye inflammation in the active phase; 3. Have a history of eye trauma; 4. Recurrent macular membrane (ERM); 5. Participating in other clinical trials of drugs or medical devices; 6. Recent fasting blood glucose concentration greater than 8.0 mmol/L, uncontrolled diabetes; 7. Uncontrolled hypertension; 8. The levels of alanine aminotransferase and aspartate aminotransferase are higher than 80 IU/L; 9. The platelet level is lower than 150,000 or higher than 450,000/uL; 10. The hemoglobin level is lower than 12.0g/dL (male) or 11.0g/dL (female); 11. No anticoagulant drugs are used, the prothrombin time is higher than 16s, and the activated partial thrombin time is higher than 35s; 12. Can not tolerate local anesthesia and are allergic to ocular surface anesthetics; 13. The subject lacks compliance with the research; 14. Current signs of systemic infection, including fever and being treated with antibiotics; 15. Chest CT showed signs of new coronary pneumonia infection or a positive nucleic acid test; 16. Systemic diseases in the active phase.

Design outcomes

Primary

MeasureTime frame
Incidence of complicated cataract;

Secondary

MeasureTime frame
Postoperative central retinal thickness;Best corrected visual acuity after operation;Operation time;

Countries

China

Contacts

Public ContactXie Zhenggao

Drum Tower Hospital Affiliated to Medical College of Nanjing University

zgxie87@163.com+86 18051060800

Outcome results

None listed

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