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

NCT05631054 | Unknown

• 1 other identifier: TianjinMUEHhbj789
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

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.

Conditions

Proliferative Diabetic Retinopathy; Pars Plana Vitrectomy; Risk Prediction Model

Outcome Measures

Primary Outcomes (1)

• Best corrected visual acuity at the last follow-up

  Standard logarithmic visual acuity scale

  1 year

Secondary Outcomes (3)

• The occurrence of re-vitrectomy

  1 year

• The occurrence of neovascular glaucoma

  1 year

• The occurrence of vitrectomy for the fellow eye

  1 year

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tianjin Medical University Eye Hospital: lead

Study Sites (1)

Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

RECRUITING

Related Publications (1)

• Nie Z, Xing W, Zhang X, Li X, Li W, Hu B. Association between stress hyperglycemia ratio and diabetic retinopathy progression and surgical prognosis: insights from NHANES 2005-2018 and clinical cohort study. Diabetol Metab Syndr. 2025 Jul 16;17(1):271. doi: 10.1186/s13098-025-01839-w.

  PMID: 40671060 DERIVED

Central Study Contacts

Bojie Hu

CONTACT

13612130943; bhu07@tmu.edu.cn

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 20, 2022
• First Posted: November 30, 2022
• Study Start: November 10, 2022
• Primary Completion: June 30, 2023
• Study Completion: June 30, 2023
• Last Updated: November 30, 2022

Record last verified: 2022-11

Locations

CN (1)