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

Sponsor
Tianjin Medical University Eye Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05631054
Collaborator
(none)
250
Enrollment
1
Location
7.6
Anticipated Duration (Months)
32.8
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    250 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Retrospective
    Official Title:
    Establishment and Validation of a Risk Prediction Model for Long-term Low Vision After Vitrectomy in Proliferative Diabetic Retinopathy Patients
    Actual Study Start Date :
    Nov 10, 2022
    Anticipated Primary Completion Date :
    Jun 30, 2023
    Anticipated Study Completion Date :
    Jun 30, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Best corrected visual acuity at the last follow-up [1 year]

      Standard logarithmic visual acuity scale

    Secondary Outcome Measures

    1. The occurrence of re-vitrectomy [1 year]

      The occurrence and indication of re-vitrectomy during the follow-up period

    2. The occurrence of neovascular glaucoma [1 year]

      Non-contact computerized tonometer (CT-1, Topcon, Japan) and slit-lamp biomicroscopy

    3. The occurrence of vitrectomy for the fellow eye [1 year]

      The occurrence of vitrectomy for the fellow eye during the follow-up period

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tianjin medical university eye hosipital Tianjin Tianjin China

    Sponsors and Collaborators

    • Tianjin Medical University Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Bojie Hu, Professor, Tianjin Medical University Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT05631054
    Other Study ID Numbers:
    • TianjinMUEHhbj789
    First Posted:
    Nov 30, 2022
    Last Update Posted:
    Nov 30, 2022
    Last Verified:
    Nov 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Vision, Low
    Retinal Diseases
    Diabetic Retinopathy

    Study Results

    No Results Posted as of Nov 30, 2022