NCT02959242

Brief Summary

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
55mo left

Started Jan 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jan 2006Dec 2030

Study Start

First participant enrolled

January 1, 2006

Completed
10.9 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2016

Completed
14.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

February 4, 2025

Status Verified

February 1, 2025

Enrollment Period

24.9 years

First QC Date

November 7, 2016

Last Update Submit

February 3, 2025

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Angle-ClosureGlaucoma, Low Tension

Keywords

Follow-up intervalsTreatment EfficiencyLaser TherapyGlaucoma SurgeryMinimal Invasive Glaucoma Surgery (MIGS)

Outcome Measures

Primary Outcomes (1)

  • Follow-up intervals

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

    20 years

Secondary Outcomes (3)

  • Assessment of treatment quality

    20 years

  • 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

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Glaucoma patients attending a tertiary University Hospital glaucoma Service.

You may qualify if:

  • manifest glaucoma, ocular Hypertension, glaucoma suspect

You may not qualify if:

  • under 18 years of age, corneal diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Eye Hospital, Medical Faculty, Technical University Dresden

Dresden, Saxony, 01307, Germany

RECRUITING

Related Publications (3)

  • Pillunat KR, Herber R, Jamke M, Jasper CS, Haase MA, Manseck AS, Pillunat LE. Early Results of Preserflo MicroShunt for Primary Open Angle Glaucoma in White Patients. J Glaucoma. 2025 Feb 1;34(2):103-113. doi: 10.1097/IJG.0000000000002509. Epub 2024 Oct 11.

    PMID: 39401481DERIVED

  • Jamke M, Herber R, Haase MA, Jasper CS, Pillunat LE, Pillunat KR. PRESERFLO MicroShunt versus trabeculectomy: 1-year results on efficacy and safety. Graefes Arch Clin Exp Ophthalmol. 2023 Oct;261(10):2901-2915. doi: 10.1007/s00417-023-06075-4. Epub 2023 May 3.

    PMID: 37133501DERIVED

  • Pillunat KR, Kocket GA, Herber R, Jasper CS, Lenk J, Pillunat LE. Efficacy of selective laser trabeculoplasty on lowering intraocular pressure fluctuations and nocturnal peak intraocular pressure in treated primary open-angle glaucoma patients. Graefes Arch Clin Exp Ophthalmol. 2023 Jul;261(7):1979-1985. doi: 10.1007/s00417-022-05897-y. Epub 2022 Nov 23.

    PMID: 36418515DERIVED

MeSH Terms

Conditions

GlaucomaGlaucoma, Open-AngleGlaucoma, Angle-ClosureLow Tension Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesOptic Nerve Diseases

Study Officials

  • Lutz E Pillunat, MD, PhD

    Medical faculty of the Technical University of Dresden, Germany

    STUDY DIRECTOR

Central Study Contacts

Karin R Pillunat, MD

CONTACT

+49 351 458 3274karin.pillunat@uniklinikum-dresden.de

Lutz E Pillunat, MD, PhD

CONTACT

+49 351 458 3381lutze.pillunat@uniklinikum-dresden.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr. med.

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 9, 2016

Study Start

January 1, 2006

Primary Completion (Estimated)

December 1, 2030

Study Completion (Estimated)

December 1, 2030

Last Updated

February 4, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Individual participant data are only shared between researchers of our Institute.

Locations

DE(1)