Glaucoma Open-AngleNCT04381611
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 of Glaucoma Open-Angle and Glaucoma Eye, run by Dr. Kaweh Mansouri at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 1 year to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Glaucoma Open-Angle, Glaucoma Eye, Glaucoma; Drugs
- How many people
- 30,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- 15 Jan 2019to 15 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Any patient suffering or suspected of glaucoma and treated at Montchoisi Clinic
Who may be able to join
- 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
Who cannot join
- Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
- Conditions
- Glaucoma Open-Angle, Glaucoma Eye, Glaucoma; Drugs, Glaucoma, Angle-Closure, Glaucoma Secondary, Glaucoma, Neovascular
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma, Glaucoma, Angle-Closure, Glaucoma, Neovascular, Hydrophthalmos, Exfoliation Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Glaucoma | Not described | |
| Glaucoma Surgery | Not described | |
| Glaucoma Laser | Not described | |
| Glaucoma Surgery Combined | Not described | |
| Glaucoma treatment | Not described | |
| Glaucoma imaging | Not described | |
| Glaucoma co-morbidity | Not described | |
| Glaucoma untreated | Not described | |
| Glaucoma Suspect | Not described | |
| Secondary Glaucoma | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with IOP reduction mmHg
Final Intra Ocular Pressure <20% compared to baseline
Measured: 12 month
Patients with quantitative OCT variations ( RNFL, μm)
Variation of RNFL before and after treatment ( laser, surgery, drug..)
Measured: 12 month
Number of patients with quantitative VF variation ( MD, dB)
Visual Field MD variation before and after treatment ( laser, surgery, drug..)
Measured: 12 month
Number of patients with quantitative VF variation (LV, dB)
Visual Field MD variation before and after treatment ( laser, surgery, drug..)
Measured: 12 months
Secondary outcomes (6)
Number of operations received by a patients
Number of operations undertaken by each patient
Measured: 12 month
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,...)
Measured: 12 month
Number of lowering IOP drugs ( molecules) taken by each patient
Number of molecules used by each patient (e.g Cosopt: 2 molecules, Xalatan: 1...)
Measured: 12 month
Anterior segment OCT variations: ACA (°), SSA (°)
variations of these measurements before and after procedure ( surgery or laser)
Measured: 12 month
Anterior segment OCT variations: AOD (mm)
variations of these measurements before and after procedure ( surgery or laser)
Measured: 12 month
Anterior segment OCT variations: TISA (mm2)
variations of these measurements before and after procedure ( surgery or laser)
Measured: 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start15 Jan 2019
- Primary completion15 Jan 2030 (estimated)
- Study completion15 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma Open-AngleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 30,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Dr. Kaweh Mansouri
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Kaweh Mansouri, Swiss Vision Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04381611
- Sponsor's protocol ID
- INTEGRAL
- Status last verified
- May 2022
- First submitted
- 30 Apr 2020
- Last updated
- 5 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04381611
- Acronym / sponsor ID
- INTEGRAL
- Conditions
- Glaucoma Open-Angle, Glaucoma Eye, Glaucoma; Drugs, Glaucoma, Angle-Closure, Glaucoma Secondary, Glaucoma, Neovascular
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Dr. Kaweh MansouriUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 15 Jan 2030 (estimated)
- Study completion
- 15 Jan 2030 (estimated)
- First posted
- 11 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 10 Years
- Number of arms
- 10
| Arm | Type | Receives |
|---|---|---|
| Primary Glaucoma | – | – |
| Glaucoma Surgery | – | – |
| Glaucoma Laser | – | – |
| Glaucoma Surgery Combined | – | – |
| Glaucoma treatment | – | – |
| Glaucoma imaging | – | – |
| Glaucoma co-morbidity | – | – |
| Glaucoma untreated | – | – |
| Glaucoma Suspect | – | – |
| Secondary Glaucoma | – | – |
Who may qualify
- Ages
- 1 year to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient suffering or suspected of glaucoma and treated at Montchoisi Clinic
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patient who are unable to understand the implications of their inclusion in the study or who are unable or unwilling to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with IOP reduction mmHg
Time frame: 12 month
Final Intra Ocular Pressure <20% compared to baseline
Patients with quantitative OCT variations ( RNFL, μm)
Time frame: 12 month
Variation of RNFL before and after treatment ( laser, surgery, drug..)
Number of patients with quantitative VF variation ( MD, dB)
Time frame: 12 month
Visual Field MD variation before and after treatment ( laser, surgery, drug..)
Number of patients with quantitative VF variation (LV, dB)
Time frame: 12 months
Visual Field MD variation before and after treatment ( laser, surgery, drug..)
6 secondary outcomes
Number of operations received by a patients
Time frame: 12 month
Number of patients undergoing a specific ocular surgical or laser procedure
Time frame: 12 month
Number of lowering IOP drugs ( molecules) taken by each patient
Time frame: 12 month
Anterior segment OCT variations: ACA (°), SSA (°)
Time frame: 12 month
Anterior segment OCT variations: AOD (mm)
Time frame: 12 month
Anterior segment OCT variations: TISA (mm2)
Time frame: 12 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2022.
- Derived from this study: PubMed 32890108Meduri 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma Open-Angle and Glaucoma Eye, run by Dr. Kaweh Mansouri at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 5 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with IOP reduction mmHg (time frame: 12 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04381611, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2022.