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

Proliferative Diabetic Retinopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05631054
• Other study ID #: TianjinMUEHhbj789
• Status: Recruiting
• Start date: November 10, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: November 2022
• Source: Tianjin Medical University Eye Hospital
• Contact: Bojie Hu
• Phone: 13612130943
• Email: bhu07[@]tmu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Retinopathy
• Pars Plana Vitrectomy
• Proliferative Diabetic Retinopathy
• Retinal Diseases
• Vision, Low

Locations

Country	Name	City	State
China	Tianjin medical university eye hosipital	Tianjin	Tianjin

Sponsors (1)

Lead Sponsor	Collaborator
Tianjin Medical University Eye Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity at the last follow-up	Standard logarithmic visual acuity scale	1 year
Secondary	The occurrence of re-vitrectomy	The occurrence and indication of re-vitrectomy during the follow-up period	1 year
Secondary	The occurrence of neovascular glaucoma	Non-contact computerized tonometer (CT-1, Topcon, Japan) and slit-lamp biomicroscopy	1 year
Secondary	The occurrence of vitrectomy for the fellow eye	The occurrence of vitrectomy for the fellow eye during the follow-up period	1 year