NCT04381611

Brief Summary

The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective (for patients operated and data recorded before 2018) and prospective (for data collected after 2018) in nature.Patients' medical data contained in the register will be analysed to determine the efficacy of the treatments they received during their follow-up at the investigation centre.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
30,000

participants targeted

Target at P75+ for all trials

Timeline
45mo left

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

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 Progress66%
Jan 2019Jan 2030

Study Start

First participant enrolled

January 15, 2019

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2020

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 15, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 15, 2030

Last Updated

May 5, 2022

Status Verified

May 1, 2022

Enrollment Period

11 years

First QC Date

April 30, 2020

Last Update Submit

May 4, 2022

Conditions

Glaucoma Open-AngleGlaucoma EyeGlaucoma; DrugsGlaucoma, Angle-ClosureGlaucoma SecondaryGlaucoma, NeovascularGlaucoma CongenitalSurgeryGlaucoma, PigmentaryGlaucoma Capsulare

Outcome Measures

Primary Outcomes (4)

  • Number of patients with IOP reduction mmHg

    Final Intra Ocular Pressure \<20% compared to baseline

    12 month

  • Patients with quantitative OCT variations ( RNFL, μm)

    Variation of RNFL before and after treatment ( laser, surgery, drug..)

    12 month

  • Number of patients with quantitative VF variation ( MD, dB)

    Visual Field MD variation before and after treatment ( laser, surgery, drug..)

    12 month

  • Number of patients with quantitative VF variation (LV, dB)

    Visual Field MD variation before and after treatment ( laser, surgery, drug..)

    12 months

Secondary Outcomes (6)

  • Number of operations received by a patients

    12 month

  • Number of patients undergoing a specific ocular surgical or laser procedure

    12 month

  • Number of lowering IOP drugs ( molecules) taken by each patient

    12 month

  • Anterior segment OCT variations: ACA (°), SSA (°)

    12 month

  • Anterior segment OCT variations: AOD (mm)

    12 month

  • +1 more secondary outcomes

Study Arms (10)

Primary Glaucoma

Glaucoma Surgery

Glaucoma Laser

Glaucoma Surgery Combined

Glaucoma treatment

Glaucoma imaging

Glaucoma co-morbidity

Glaucoma untreated

Glaucoma Suspect

Secondary Glaucoma

Eligibility Criteria

Age1 Year - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Any patient suffering or suspected of glaucoma and treated at Montchoisi Clinic

You may qualify if:

  • Diagnosis of glaucoma (open-angle, closed-angle, primary or secondary) or ocular hypertension (IOP \> 24 mmHg, medicated or not)
  • Patients who received treatment (medical, laser or surgical) at the Glaucoma Centre, Montchoisi Clinic
  • Able and willing to provide informed written or verbal consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SwissVisio Montchoisi

Lausanne, Canton of Vaud, 1006, Switzerland

Location

Related Publications (1)

  • Meduri E, Gillmann K, Bravetti GE, Niegowski LJ, Mermoud A, Weinreb RN, Mansouri K. Iridocorneal Angle Assessment After Laser Iridotomy With Swept-source Optical Coherence Tomography. J Glaucoma. 2020 Nov;29(11):1030-1035. doi: 10.1097/IJG.0000000000001654.

    PMID: 32890108DERIVED

MeSH Terms

Conditions

Glaucoma, Open-AngleGlaucomaGlaucoma, Angle-ClosureGlaucoma, NeovascularHydrophthalmosExfoliation Syndrome

Condition Hierarchy (Ancestors)

Ocular HypertensionEye DiseasesEye AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesIris DiseasesUveal Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor UC Denver

Study Record Dates

First Submitted

April 30, 2020

First Posted

May 11, 2020

Study Start

January 15, 2019

Primary Completion (Estimated)

January 15, 2030

Study Completion (Estimated)

January 15, 2030

Last Updated

May 5, 2022

Record last verified: 2022-05

Locations

CH(1)