Clinical Trials Logo

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT06227299
Other study ID # INTEGRAL
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date May 29, 2018
Est. completion date January 2030

Study information

Verified date January 2024
Source Swiss Glaucoma Research Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial Summary

The aim of this study is to create a large-scale register of all glaucoma patients diagnosed, followed and treated in a large tertiary centre specialising in glaucoma, in order to analyse whether specific factors influence the progression of the disease or guide our choice of treatment. This should lead to a better understanding of the disease and the factors to be taken into account when choosing the best treatment option for each patient, leading to safer, more effective and patient-centred care.


Description:

Glaucoma encompasses a group of chronic diseases characterized by progressive retinal nerve fibre loss and a concomitant pattern of visual field damage, eventually leading to blindness. To date, it is still considered the first cause of irreversible blindness worldwide. In recent years, treatment options for glaucoma have soared, and ophthalmologists can resort to a wide selection of drops, laser procedures and surgical techniques to reduce intraocular pressure, and slow the progression of the disease. The choice of the technique, however, often depends on personal preferences and it is still unclear if a specific technique is more efficient or safe, or if any patient-depending factors should guide the choice of treatment. The aim of this study is to create a large-scale register of all glaucomatous patients diagnosed, followed-up and treated in a large glaucoma-specialised tertiary centre, to analyse if any specific factor influence the progression of the disease or guide our treatment choice. This should lead to a better understanding of the disease itself and of the factors that should be considered when choosing the best treatment option for each patient, leading to safer, more efficient and more patient-centered care. This registry is thus of great importance for both patients and clinicians in the diagnosis and treatment of glaucoma. The study is an observational analysis of patients' medical data recorded in a large-scale register, both retrospective and prospective.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 5000
Est. completion date January 2030
Est. primary completion date August 30, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - 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 and Swiss Visio Montchoisi - Age: 18 years old or older - Able and willing to provide informed written or verbal consent Exclusion Criteria: - Patients who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Swiss Visio Montchoisi Lausanne Vaud

Sponsors (1)

Lead Sponsor Collaborator
Swiss Glaucoma Research Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary IOP changes intraocular pressure (IOP) values compared to baseline 2 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
Primary Number of molecules • number of IOP-lowering medications required to maintain the IOP within therapeutic targets compared to baseline 2 months, 6 months, 12 months, 24 months, 36 months, 48 months, 60 months
See also
  Status Clinical Trial Phase
Recruiting NCT06000865 - Glaucoma Rehabilitation With Action viDeo Games and Exercise - GRADE N/A
Recruiting NCT06278597 - Automatic Evaluation of the Anterior Chamber Angle Width by a New Non-contact Optical Device N/A
Active, not recruiting NCT04271709 - Manhattan Vision Screening and Follow-Up Study (NYC-SIGHT) N/A
Recruiting NCT03274024 - The Asia Primary Tube Versus Trab (TVT) Study N/A
Completed NCT04552964 - Assessment of the Impact of an add-on and Its Smartphone Application on the Daily Management of Glaucoma N/A
Recruiting NCT01957267 - Functional and Structural Imaging for Glaucoma
Active, not recruiting NCT04624698 - iStent Inject New Enrollment Post-Approval Study N/A
Completed NCT04020705 - The Efficacy of Citicoline in Eyedrops (OMK1) in Reducing the Progression of Glaucoma N/A
Completed NCT03150160 - Additive Effect of Twice-daily Brinzolamide 1%/Brimonidine 0.2%Combination as an Adjunctive Therapy to Travoprost in Patients With Normal Tension Glaucoma Phase 4
Not yet recruiting NCT05581498 - Glaucoma Exercise as Medicine Study (GEMS). N/A
Recruiting NCT02921568 - Side-by-Side Comparison of P200TE and Spectral OCT/SLO on Diseased Eyes N/A
Active, not recruiting NCT02901730 - Clinical Study of LPI With Different Laser Wavelengths N/A
Completed NCT02955849 - A Trial of China Laser and Surgery Study Glaucoma in Rural China Early Phase 1
Recruiting NCT02554214 - Pilot Clinical Trial on a New Adjustable Glaucoma Drainage Device N/A
Recruiting NCT02471105 - Investigation of IOP and Tolerability of Bimatoprost 0.01% and Tafluprost Unit Dose Preservative Free 15 Microgram/ml Phase 4
Active, not recruiting NCT02390284 - Stop Retinal Ganglion Cell Dysfunction Study Phase 3
Completed NCT02520674 - Glaucoma Screening With Smartphone Ophthalmology N/A
Completed NCT02390245 - Philadelphia Telemedicine Glaucoma Detection and Follow-Up Study N/A
Completed NCT02653963 - Triamcinolone for Ahmed Glaucoma Valve N/A
Completed NCT02246764 - Study of Netarsudil (AR-13324) Ophthalmic Solution in Patients With Glaucoma or Ocular Hypertension Phase 3