Clinical trial NCT05631054: Establishment and Validation of a Risk Prediction Model for Long-term Low Vision After Vitrectomy in PDR Patients
Official title: Establishment and Validation of a Risk Prediction Model for Long-term Low Vision After Vitrectomy in Proliferative Diabetic Retinopathy Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proliferative Diabetic Retinopathy
Pars Plana Vitrectomy
Risk Prediction Model
Lead sponsor: Tianjin Medical University Eye Hospital
Sponsor class: OTHER
First posted: 2022-11-30
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Best corrected visual acuity at the last follow-up
timeFrame: 1 year
Secondary outcomes:
measure: The occurrence of re-vitrectomy
timeFrame: 1 year
measure: The occurrence of neovascular glaucoma
timeFrame: 1 year
measure: The occurrence of vitrectomy for the fellow eye
timeFrame: 1 year
Other outcomes:
Locations:
city: Tianjin
country: China
facility: Tianjin medical university eye hosipital
state: Tianjin
Study officials:
References: