GlaucomaNCT03807869
Reduction of Intraocular Pressure After I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
A study testing combined glaucoma surgery in people with Glaucoma, run by Medical University of Bialystok at 1 site in Poland.
Trial summary
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Glaucoma
- What is being tested?
- combined glaucoma surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- 1 sitePoland
- Study dates
- 1 Dec 2018to 1 Feb 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacity Classification System III)
- patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), with topical hypotensive treatment
- written consent to involvement and participation in the study for a period of at least 12 months was obtained from all patients after they had first been informed of the nature of the procedure and other surgical alternatives
Who cannot join
- no consent to participation in the study
- prior surgical and laser procedures in the area of the eye
- narrow- or closed-angle glaucoma
- post-inflammatory or post-traumatic secondary glaucoma
- chronic illness of the cornea or optic nerve
- advanced macular degeneration
Show all 9Show fewer
- active inflammatory process
- pregnancy
- systemic steroid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.
Read the detailed description
The scientific aim of the project is to estimate the average reduction of intraocular pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12 months observation period. The subject must suffer from glaucoma and cataract at the same time, and qualify for a cataract surgery. The group will be composed of 40 patients of the Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract removal surgery. They will be surgically implanted an I-stent by-pass during phacoemulsification.
- Conditions
- Glaucoma
- Being tested
- combined glaucoma surgery
- Keywords
- I-stent, glaucoma surgery, minimally invasive glaucoma surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined glaucoma surgeryProcedure or surgery
phacoemulsification of cataract and I-stent by-pass implantation
| Study group | Role | What they receive |
|---|---|---|
| coexisting glaucoma and cataract | Experimental | Patients with coexisting glaucoma and cataract qualified to combined glaucoma surgery Receives: Procedure: combined glaucoma surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
IntraOcular Pressure measurement (IOP)
change in the level of intraocular pressure measured with Goldmann applanation tonometer
Measured: baseline, 12 months
Best Corrected Visual Acuity measurement (BCVA)
change in best corrected visual acuity measured with Snellen charts
Measured: baseline, 12 months
Secondary outcomes (1)
number of antiglaucoma medicines
change in number of antiglaucoma medicines used before and after surgery
Measured: baseline, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2019
- Study start1 Dec 2018
- Primary completion1 Dec 2019
- Study completion1 Feb 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Bialystok
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zofia Mariak, Prof, Study chair, Medical University of Bialystok
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03807869
- Sponsor's protocol ID
- 1772
- Status last verified
- Feb 2020
- First submitted
- 15 Jan 2019
- Last updated
- 13 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data for all primary and secondary outcome measures will be made available
Publications
Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.
PubMed 29476443Chansangpetch S, Lau K, Perez CI, Nguyen N, Porco TC, Lin SC. Efficacy of Cataract Surgery With Trabecular Microbypass Stent Implantation in Combined-Mechanism Angle Closure Glaucoma Patients. Am J Ophthalmol. 2018 Nov;195:191-198. doi: 10.1016/j.ajo.2018.08.003. Epub 2018 Aug 8.
PubMed 30098352Kozera M, Konopinska J, Mariak Z, Rekas M. Effectiveness of iStent Trabecular Microbypass System Combined with Phacoemulsification versus Phacoemulsification Alone in Patients with Glaucoma and Cataract Depending on the Initial Intraocular Pressure. Ophthalmic Res. 2021;64(2):327-336. doi: 10.1159/000511456. Epub 2020 Sep 9.
PubMed 32906138Konopinska J, Kozera M, Krasnicki P, Mariak Z, Rekas M. The Effectiveness of First-Generation iStent Microbypass Implantation Depends on Initial Intraocular Pressure: 24-Month Follow-Up-Prospective Clinical Trial. J Ophthalmol. 2020 Jun 23;2020:8164703. doi: 10.1155/2020/8164703. eCollection 2020.
PubMed 32676205
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of I-stent By-pass Implantation in Eyes With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT03807869
- Acronym / sponsor ID
- 1772
- Conditions
- Glaucoma
- Keywords
- I-stent, glaucoma surgery, minimally invasive glaucoma surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Medical University of BialystokUniversity, hospital or other
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 1 Dec 2019 (actual)
- Study completion
- 1 Feb 2020 (actual)
- First posted
- 17 Jan 2019 (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.
Purpose of this study is to exam the hypotensive effectiveness of I-stent implantation depended on number of antiglaucoma eye drops at baseline.
Detailed description
The scientific aim of the project is to estimate the average reduction of intraocular pressure (IOP) in relation to the initial number of antiglaucoma drops at the end of 12 months observation period. The subject must suffer from glaucoma and cataract at the same time, and qualify for a cataract surgery. The group will be composed of 40 patients of the Ophthalmology Clinic of the Medical University of Białystok qualified for planned cataract removal surgery. They will be surgically implanted an I-stent by-pass during phacoemulsification.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| coexisting glaucoma and cataract | Experimental | Procedure: combined glaucoma surgeryPatients with coexisting glaucoma and cataract qualified to combined glaucoma surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- co-existing glaucoma and cataract (NC1, NC2) classified by means of the LOCS III scale (Lens Opacity Classification System III)
- patients with primary open-angle glaucoma (POAG), pseudoexfoliative glaucoma (PGX) and normal tension glaucoma (NTG), with topical hypotensive treatment
- written consent to involvement and participation in the study for a period of at least 12 months was obtained from all patients after they had first been informed of the nature of the procedure and other surgical alternatives
Key exclusion criteria (9 listed)
- no consent to participation in the study
- prior surgical and laser procedures in the area of the eye
- narrow- or closed-angle glaucoma
- post-inflammatory or post-traumatic secondary glaucoma
- chronic illness of the cornea or optic nerve
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 |
|---|---|---|
| combined glaucoma surgeryphacoemulsification of cataract and I-stent by-pass implantation | Procedure or surgery | coexisting glaucoma and cataract |
Primary outcome
IntraOcular Pressure measurement (IOP)
Time frame: baseline, 12 months
change in the level of intraocular pressure measured with Goldmann applanation tonometer
Best Corrected Visual Acuity measurement (BCVA)
Time frame: baseline, 12 months
change in best corrected visual acuity measured with Snellen charts
1 secondary outcome
number of antiglaucoma medicines
Time frame: baseline, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2020.
- Background: PubMed 29476443Myers JS, Masood I, Hornbeak DM, Belda JI, Auffarth G, Junemann A, Giamporcaro JE, Martinez-de-la-Casa JM, Ahmed IIK, Voskanyan L, Katz LJ. Prospective Evaluation of Two iStent(R) Trabecular Stents, One iStent Supra(R) Suprachoroidal Stent, and Postoperative Prostaglandin in Refractory Glaucoma: 4-year Outcomes. Adv Ther. 2018 Mar;35(3):395-407. doi: 10.1007/s12325-018-0666-4. Epub 2018 Feb 23.
- Results publication: PubMed 30098352Chansangpetch S, Lau K, Perez CI, Nguyen N, Porco TC, Lin SC. Efficacy of Cataract Surgery With Trabecular Microbypass Stent Implantation in Combined-Mechanism Angle Closure Glaucoma Patients. Am J Ophthalmol. 2018 Nov;195:191-198. doi: 10.1016/j.ajo.2018.08.003. Epub 2018 Aug 8.
- Derived from this study: PubMed 32906138Kozera M, Konopinska J, Mariak Z, Rekas M. Effectiveness of iStent Trabecular Microbypass System Combined with Phacoemulsification versus Phacoemulsification Alone in Patients with Glaucoma and Cataract Depending on the Initial Intraocular Pressure. Ophthalmic Res. 2021;64(2):327-336. doi: 10.1159/000511456. Epub 2020 Sep 9.
- Derived from this study: PubMed 32676205Konopinska J, Kozera M, Krasnicki P, Mariak Z, Rekas M. The Effectiveness of First-Generation iStent Microbypass Implantation Depends on Initial Intraocular Pressure: 24-Month Follow-Up-Prospective Clinical Trial. J Ophthalmol. 2020 Jun 23;2020:8164703. doi: 10.1155/2020/8164703. eCollection 2020.
- Individual participant dataSharing planned: Yes. De-identified individual participant data for all primary and secondary outcome measures will be made available
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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.
Zofia Mariak, Prof study chair
Medical University of Bialystok
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing combined glaucoma surgery in people with Glaucoma, run by Medical University of Bialystok 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 3 inclusion and 9 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: finished, as of the sponsor's last update on 13 Feb 2020. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
IntraOcular Pressure measurement (IOP) (time frame: baseline, 12 months). The study lists 2 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 NCT03807869, which also lists 4 linked publications.
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 13 Feb 2020.