Skip to content

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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05631054
Enrollment
250
Registered
2022-11-30
Start date
2022-11-10
Completion date
2023-06-30
Last updated
2022-11-30

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

Conditions

Pars Plana Vitrectomy, Proliferative Diabetic Retinopathy, Risk Prediction Model

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.

Interventions

None listed

Sponsors

Tianjin Medical University Eye Hospital
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Best corrected visual acuity at the last follow-up1 yearStandard logarithmic visual acuity scale

Secondary

MeasureTime frameDescription
The occurrence of re-vitrectomy1 yearThe occurrence and indication of re-vitrectomy during the follow-up period
The occurrence of neovascular glaucoma1 yearNon-contact computerized tonometer (CT-1, Topcon, Japan) and slit-lamp biomicroscopy
The occurrence of vitrectomy for the fellow eye1 yearThe occurrence of vitrectomy for the fellow eye during the follow-up period

Countries

China

Contacts

Primary ContactBojie Hu
bhu07@tmu.edu.cn13612130943

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026