Skip to main content
Clinical Trials/NCT05631054
NCT05631054
Recruiting
Not Applicable

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

Tianjin Medical University Eye Hospital1 site in 1 country250 target enrollmentNovember 10, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Proliferative Diabetic Retinopathy
Sponsor
Tianjin Medical University Eye Hospital
Enrollment
250
Locations
1
Primary Endpoint
Best corrected visual acuity at the last follow-up
Status
Recruiting
Last Updated
3 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
November 10, 2022
End Date
June 30, 2023
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Bojie Hu

Professor

Tianjin Medical University Eye Hospital

Eligibility Criteria

Inclusion Criteria

  • Voluntary and able to sign an informed consent form
  • Age ≥18 years
  • Documented 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-up
  • Previous intraocular surgery (eg. corneal transplantation, glaucoma filtering, vitrectomy, except cataract surgery)
  • Complicated with other retinal diseases
  • Underwent surgery (eg. intravitreal injection, cataract surgery) of the study eye within 3 months
  • Lack of medical records.

Outcomes

Primary Outcomes

Best corrected visual acuity at the last follow-up

Time Frame: 1 year

Standard logarithmic visual acuity scale

Secondary Outcomes

  • The occurrence of re-vitrectomy(1 year)
  • The occurrence of neovascular glaucoma(1 year)
  • The occurrence of vitrectomy for the fellow eye(1 year)

Study Sites (1)

Loading locations...

Similar Trials