Dresden Glaucoma and Treatment Study (DGTS)

Sponsor
Technische Universität Dresden (Other)
Overall Status
Recruiting
CT.gov ID
NCT02959242
Collaborator
(none)
10,000
1
251
39.8

Study Details

Study Description

Brief Summary

To assure the quality of follow-up and treatment, data of glaucoma patients are stored and evaluated after anonymisation.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The aim of the study is to evaluate the quality of follow-up and treatment by means of consecutive data collection and anonymised analysis of all glaucoma patients of a tertiary university hospital glaucoma service.

    Parameters being analyzed are:

    Age, sex, refraction, family history, known duration of glaucoma, highest intraocular pressure before treatment, systemic and topical medication, previous ocular surgery.

    24h Goldmann-applanation tonometry, biomicroscopy, gonioscopy, Heidelberg Retinal Tomograph (HRT), glaucoma diagnosis with Scanning-Laser-Polarimetry (GDx), optical coherence tomography (OCT), Pentacam, Ocular Response Analyzer (ORA), Corvis ST (Corneal Visualization with the Scheimpflug Technology), perimetry

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Dresden Glaucoma and Treatment Study: Analysis to Assure the Quality of Follow-up and Therapy of Glaucoma Patients in a Tertiary University Hospital Glaucoma Service.
    Study Start Date :
    Jan 1, 2006
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Follow-up intervals [20 years]

      To find the best follow-up intervals for glaucoma patients.

    Secondary Outcome Measures

    1. Assessment of treatment quality [20 years]

      What is the best treatment option for the individual patient?

    2. Assessment of intraocular pressure-lowering efficacy and number of participants with treatment-related adverse events as assessed by CTCAE v4.0 of glaucoma laser therapy [20 years]

      Diurnal intraocular pressure, best corrected visual acuity, visual fields

    3. Assessment of intraocular pressure-lowering efficacy and number of participants with treatment-related adverse events as assessed by CTCAE v4.0 of glaucoma laser therapy of glaucoma surgery [20 years]

      Diurnal intraocular pressure, best corrected visual acuity, visual fields

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • manifest glaucoma, ocular Hypertension, glaucoma suspect
    Exclusion Criteria:
    • under 18 years of age, corneal diseases

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University Eye Hospital, Medical Faculty, Technical University Dresden Dresden Saxony Germany 01307

    Sponsors and Collaborators

    • Technische Universität Dresden

    Investigators

    • Study Director: Lutz E Pillunat, MD, PhD, Medical faculty of the Technical University of Dresden, Germany

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Dr. Karin Pillunat, Dr. med., Technische Universität Dresden
    ClinicalTrials.gov Identifier:
    NCT02959242
    Other Study ID Numbers:
    • DGTS
    First Posted:
    Nov 9, 2016
    Last Update Posted:
    Mar 29, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Dr. Karin Pillunat, Dr. med., Technische Universität Dresden
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 29, 2022