GlaucomaNCT03613233
QoL Assessment in Traditional Glaucoma Surgery and MIGS.
A study testing Glaucoma surgery in people with Glaucoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
Trial summary
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Glaucoma surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 sitePoland
- Study dates
- 1 Jan 2018to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:
- all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
- patients not tolerating antiglaucoma medications,
- patients with poor compliance
- progression in visual field
Who cannot join
- active inflammatory disease
- pregnancy
- mental disease or emotional instability
- general steroid therapy
- inability to fill in the questionnaire
Trial locations and contacts
1 site in 1 country.
Marek Rękas, prof.; MD; PhD contact
Poland1 site, 1 recruiting
- Recruiting
Military Institute of Medicine
Warsaw, 04-141
Anna Byszewska, MD,PhD, 500285890 ext. 48, ania.byszewska@gmail.com
About this study
Official title: Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).
Read the detailed description
Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.
- Conditions
- Glaucoma
- Being tested
- Glaucoma surgery
- Keywords
- MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL, quality of life, NEI VFQ 25
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma surgeryProcedure or surgery
Also called cataract surgery when required
phacoemulsification
| Study group | Role | What they receive |
|---|---|---|
| traditional glaucoma surgery | Active comparator | glaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy Receives: Procedure: Glaucoma surgery |
| microinvasive glaucoma surgery (MIGS) | Active comparator | glaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device Receives: Procedure: Glaucoma surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEI VFQ 25 quality of life score change
NEI VFQ 25 baseline and 3 months after surgery
Measured: baseline (0-30 days; pre-operative) and three months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2018
- Study start1 Jan 2018
- Primary completion1 Jan 2020 (estimated)
- Study completion1 Apr 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Military Institute od Medicine National Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marek Rekas, Military Institute od Medicine National Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03613233
- Sponsor's protocol ID
- 0000000417
- Status last verified
- Jul 2018
- First submitted
- 29 Jun 2018
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life Assessment in Traditional and Microinvasive Glaucoma Surgery.
- ClinicalTrials.gov ID
- NCT03613233
- Acronym / sponsor ID
- 0000000417
- Conditions
- Glaucoma
- Keywords
- MIGS, canaloplasty, glaucoma, glaucoma surgery, glaucoma implant, deep sclerectomy, iridencleisis, QoL
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Military Institute od Medicine National Research InstituteUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 3 Aug 2018 (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.
Quality of Life assessment before and after various glaucoma surgery (traditional and microinvasive (MIGS)).
Detailed description
Patients qualified for glaucoma surgical procedure fill in QoL questionnaire (NEI VFQ 25) at baseline (pre-operatively) and 3 months after glaucoma surgery. Additional data will be collected such as demographic data and medical data, visual acuity, intraocular pressure, number of glaucoma medications, stage of glaucoma based on visual field assessment, medical ophthalmic history, intra and postoperative complications, postoperative interventions.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| traditional glaucoma surgery | Active comparator | Procedure: Glaucoma surgeryglaucoma procedures such as trabeculectomy, iridencleisis, non - penetrating deep sclerectomy |
| microinvasive glaucoma surgery (MIGS) | Active comparator | Procedure: Glaucoma surgeryglaucoma procedures such as : canaloplasty (traditional, ABiC, modified), iStent, XEN, Cypass,Hydrus- and with any other microinvasive IOP reducing device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- patients qualified for glaucoma surgery in Military Institute of Medicine - based on following Inclusion Criteria:
- all glaucoma types with characteristic glaucoma changes (biomicroscopic ,visual field) with documented glaucoma progression
- patients not tolerating antiglaucoma medications,
- patients with poor compliance
- progression in visual field
Key exclusion criteria (5 listed)
- active inflammatory disease
- pregnancy
- mental disease or emotional instability
- general steroid therapy
- inability to fill in the questionnaire
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Glaucoma surgeryAlso: cataract surgery when requiredphacoemulsification | Procedure or surgery | microinvasive glaucoma surgery (MIGS), traditional glaucoma surgery |
Primary outcome
NEI VFQ 25 quality of life score change
Time frame: baseline (0-30 days; pre-operative) and three months after surgery
NEI VFQ 25 baseline and 3 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- 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. This study is not recruiting at the moment.
Marek Rękas, prof.; MD; PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma surgery in people with Glaucoma, run by Military Institute od Medicine National Research Institute at 1 site in Poland.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 3 Aug 2018. 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 Poland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Byszewska, MD, PhD (500285890 ext. 48, ania.byszewska@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NEI VFQ 25 quality of life score change (time frame: baseline (0-30 days; pre-operative) and three months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.