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

NCT ID: NCT05631054

Last Updated: 2022-11-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-10

Study Completion Date

2023-06-30

Brief Summary

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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

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Conditions

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Proliferative Diabetic Retinopathy Pars Plana Vitrectomy Risk Prediction Model

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tianjin Medical University Eye Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bojie Hu

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Tianjin medical university eye hosipital

Tianjin, Tianjin Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Bojie Hu

Role: CONTACT

Phone: 13612130943

Email: [email protected]

Facility Contacts

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Bojie Hu

Role: primary

References

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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.

Reference Type DERIVED
PMID: 40671060 (View on PubMed)

Other Identifiers

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TianjinMUEHhbj789

Identifier Type: -

Identifier Source: org_study_id