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Recruiting NCT05631054

Establishment and Validation of a Risk Prediction Model for Long-term Low Vision After Vitrectomy in PDR Patients

Conditions: Proliferative Diabetic Retinopathy, Pars Plana Vitrectomy, Risk Prediction Model

Sex: All
Ages: 18 Years – N/A
Enrollment: 250
Sponsor: Tianjin Medical University Eye Hospital

Location: China

Summary

Diabetic retinopathy (DR) is the main cause of blindness among working-age adults in the world. Proliferative diabetic retinopathy (PDR) is the severe stage of DR, which is characterized by neovascularization of the retina. Vitreous hemorrhage and traction retinal detachment caused by PDR often require vitrectomy. The purpose of vitrectomy is to remove vitreous hemorrhage, peel off the preretinal proliferative membrane and help restore the retina. With the deepening of people's understanding of diabetes and the development and application of various hypoglycemic drugs, the life expectancy of patients with diabetes continues to prolong. Therefore, the goal of vitrectomy in patients with DR is not only to prevent blindness, but also to maintain good vision for a long time. The purpose of this study is to analyze the risk factors related to the occurrence of long-term low vision postoperatively and establish a risk prediction model, which can help patients adjust their psychological expectations reasonably and promote communication between doctors and patients.

Eligibility Criteria

Inclusion Criteria:Voluntary and able to sign an informed consent formAge ≥18 yearsDocumented diagnosis of diabetes mellitus (type I or type II diabetes) defined by the American Diabetes Association or World Health Organization criteria.Unabsorbed vitreous hemorrhage lasted for more than 2 weeks, with or without tractional retinal detachment examen by slit lamp, B-ultrasound and fundus color photography.Exclusion Criteria:Patients with less than 12 months of follow-upPrevious intraocular surgery (eg. corneal transplantation, glaucoma filtering, vitrectomy, except cataract surgery)Complicated with other retinal diseasesUnderwent surgery (eg. intravitreal injection, cataract surgery) of the study eye within 3 monthsLack of medical records.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05631054). StuddyBuddy aggregates publicly available trial information.