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

Recruiting

• Conditions: Proliferative Diabetic Retinopathy; Pars Plana Vitrectomy; Risk Prediction Model

• Registration Number: NCT05631054
• Lead Sponsor: Tianjin Medical University Eye Hospital

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-11
• Study Start: 2022-11-10
• Study First Submitted: 2022-11-20
• Study First Submitted QC: 2022-11-28
• Last Update Submitted: 2022-11-28
• Study First Posted: 2022-11-30
• Last Update Posted: 2022-11-30
• Primary Completion: 2023-06-30
• Study Completion: 2023-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 250

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Best corrected visual acuity at the last follow-up	1 year	Standard logarithmic visual acuity scale

Secondary Outcome Measures

Name	Time	Method
The occurrence of re-vitrectomy	1 year	The occurrence and indication of re-vitrectomy during the follow-up period
The occurrence of neovascular glaucoma	1 year	Non-contact computerized tonometer (CT-1, Topcon, Japan) and slit-lamp biomicroscopy
The occurrence of vitrectomy for the fellow eye	1 year	The occurrence of vitrectomy for the fellow eye during the follow-up period

Trial Locations

Locations (1)

Tianjin medical university eye hosipital; 🇨🇳 Tianjin, Tianjin, China