ClinicalTrials.gg
Enrolling by invitationNCT04381611Updated May 5, 2022

INTEGRAL Study: A Longitudinal Study of Surgeries and Lasers in Glaucoma: Long-term Results and Success Predictors Analysed From a Large-scale Retrospective and Prospective Glaucoma Register

An observational study in Glaucoma Open-Angle, Glaucoma Eye and Glaucoma; Drugs, sponsored by Dr. Kaweh Mansouri. Enrolling by invitation at 1 site in Switzerland. Open to participants aged 1 Year to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-05-05.

Sponsored by Dr. Kaweh Mansouri · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
30,000
Ages
1 Year to 100 Years
Sex
All
01

Study 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.

Read the detailed description

This study involves the creation and analysis of a large-scale register including all patients suffering from glaucoma, currently and previously followed-up and treated at a single tertiary centre in Lausanne, Switzerland. The design of the study is longitudinal, observational and comparative. Patients are recruited retrospectively if they attended the research centre before September 2018, and prospectively if they attend the centre from this month onwards. Their inclusion does not affect their care, treatment choice or follow-up. All data of recruited patients is be kept in their medical notes until a specific analysis is launched. Data is then exported from their medical notes into a coded database for analysis. At the end of each analysis session (defined as the publication of the related article), all exported data is fully anonymised.

Data analysis will aim to assess the long-term efficacy, safety profile, and factors predictive of success/failure of treatments performed.

To ensure the quality of all included data, health-related information will be extracted directly from the medical notes and coded into the register by a Clinical Research Associate. Conformity of the process and recorded data will be confirmed by regular internal auditing. For quality assurance the Ethics Committee may visit the research sites. Direct access to the source data and all project related files and documents must be granted on such occasions.

02

Conditions studied

  • Glaucoma Open-Angle
  • Glaucoma Eye
  • Glaucoma; Drugs
  • Glaucoma, Angle-Closure
  • Glaucoma Secondary
  • Glaucoma, Neovascular
  • Glaucoma Congenital
  • Surgery
  • Glaucoma, Pigmentary
  • Glaucoma Capsulare
03

In context

Glaucoma, Open-Angle

924 studies on the registry are indexed under Glaucoma, Open-Angle; 117 are open to participants now.

This study's planned enrollment of 30,000 is above the median of 101 across 184 observational studies indexed under Glaucoma, Open-Angle.

Browse Glaucoma, Open-Angle studies →

Lead sponsor

Dr. Kaweh Mansouri is the lead sponsor of 3 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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
  • Able and willing to provide informed written or verbal consent

Exclusion criteria

Exclusion Criteria:

  • Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
30,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Primary Glaucoma
  • Glaucoma Surgery
  • Glaucoma Laser
  • Glaucoma Surgery Combined
  • Glaucoma treatment
  • Glaucoma imaging
  • Glaucoma co-morbidity
  • Glaucoma untreated
  • Glaucoma Suspect
  • Secondary Glaucoma
06

What researchers measure

Primary outcomes

  1. Number of patients with IOP reduction mmHg

    Final Intra Ocular Pressure \<20% compared to baseline

    Time frame: 12 month

  2. Patients with quantitative OCT variations ( RNFL, μm)

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

    Time frame: 12 month

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

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

    Time frame: 12 month

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

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

    Time frame: 12 months

Secondary outcomes

  1. Number of operations received by a patients

    Number of operations undertaken by each patient

    Time frame: 12 month

  2. Number of patients undergoing a specific ocular surgical or laser procedure

    Number of patients undertaking different types of ocular procedures ( deep sclerectomy, cataract, LPI, SLT,...)

    Time frame: 12 month

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

    Number of molecules used by each patient (e.g Cosopt: 2 molecules, Xalatan: 1...)

    Time frame: 12 month

  4. Anterior segment OCT variations: ACA (°), SSA (°)

    variations of these measurements before and after procedure ( surgery or laser)

    Time frame: 12 month

  5. Anterior segment OCT variations: AOD (mm)

    variations of these measurements before and after procedure ( surgery or laser)

    Time frame: 12 month

  6. Anterior segment OCT variations: TISA (mm2)

    variations of these measurements before and after procedure ( surgery or laser)

    Time frame: 12 month

07

Study locations

1 site
  • SwissVisio Montchoisi
    Lausanne, Vaud 1006, Switzerland
08

References and documents

Publications

  • 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. PubMed 32890108 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jan 2019 (actual). Primary completion is estimated for Jan 2030, 132 months after the start.

Of 53 observational studies under Glaucoma, Open-Angle, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 12. This study's planned 132 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 30, 2020
First posted
May 11, 2020
StartActual
Jan 15, 2019
Primary completionEst.
Jan 15, 2030
CompletionEst.
Jan 15, 2030
Last update
May 5, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 5, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04381611
Lead sponsor
Dr. Kaweh Mansouri
Responsible party
Dr. Kaweh Mansouri (Professor UC Denver, Swiss Vision Network) — Sponsor-investigator
First posted
May 11, 2020
Start date
Jan 15, 2019
Primary completion
Jan 15, 2030 (estimated)
Completion
Jan 15, 2030 (estimated)
Last update
May 5, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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No contact was published for this record. The registry link below has the sponsor’s details.

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