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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Anticipated): 250

Contacts and Locations

Study Locations

• China
  • Tianjin
    • Tianjin, Tianjin, China
      • Recruiting
      • Tianjin medical university eye hosipital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients who underwent vitrectomy for PDR in Tianjin Medical University Eye Hospital and the follow-up period is more than 12 months. They are divided into low vision and non-low vision groups based on the BCVA at the last follow-up.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity at the last follow-up	Standard logarithmic visual acuity scale	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tianjin Medical University Eye Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 10, 2022
• Primary Completion (ANTICIPATED): June 30, 2023
• Study Completion (ANTICIPATED): June 30, 2023

Study Registration Dates

• First Submitted: November 20, 2022
• First Submitted That Met QC Criteria: November 28, 2022
• First Posted (ACTUAL): November 30, 2022

Study Record Updates

• Last Update Posted (ACTUAL): November 30, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Sensation Disorders; Vision Disorders; Retinal Diseases; Diabetic Retinopathy; Vision, Low
• Other Study ID Numbers: TianjinMUEHhbj789

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No