Precision treatment for diabetic retinopathy using real-time imaging during surgery
Study on Precision Treatment of Diabetic Retinopathy Macular Edema Guided by Real-time Optical Coherence Tomography During Operation
This study is testing whether using real-time imaging during eye surgery can help people with severe diabetic eye disease get better treatment options and improve their vision.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Sponsor | Affiliated Hospital of Nantong University Academic / other |
| Locations | 1 site (Nantong, Jiangsu) |
| Trial ID | NCT05138029 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with proliferative diabetic retinopathy (PDR) who require vitrectomy due to severe vitreous hemorrhage. After obtaining informed consent, the surgery will be performed, and intraoperative optical coherence tomography (iOCT) will be used to assess the macular area in real-time. If the central macular thickness (CMT) is 250μm or greater, patients will be randomly assigned to receive one of three treatments: anti-VEGF, glucocorticoid, or internal limiting membrane stripping. The outcomes, including visual acuity and macular thickness, will be evaluated at multiple time points post-surgery.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-80 with type 2 diabetes and severe vitreous hemorrhage requiring vitrectomy.
Not a fit: Patients with severe infections, other retinal vascular diseases, or recent myocardial infarction or stroke may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve visual outcomes for patients with diabetic retinopathy and macular edema.
How similar studies have performed: Other studies utilizing real-time imaging during surgical procedures have shown promising results, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * PDR patients with severe vitreous hemorrhage who cannot collect oct images and need vitrectomy * Type 2 diabetes, aged 18\~80 years old * Good blood sugar control (glycated hemoglobin \<8.3%) * Sign the informed consent form voluntarily, and are willing and able to follow the outpatient visits and research procedures within the time specified in the trial Exclusion Criteria: * Exclude severe infections of conjunctiva, cornea, and sclera * Combined with other retinal vascular diseases such as retinal vein occlusion * Cardiorenal insufficiency * Myocardial infarction or stroke occurred within 6 months.
Where this trial is running
Nantong, Jiangsu
- Affiliated Hospital of Nantong University — Nantong, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Rongrong Zhu, master — Affiliated Hospital of Nantong University
- Study coordinator: Rongrong Zhu, Master
- Email: zrreye@126.com
- Phone: 13809089545
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.