Primary Open-angle GlaucomaNCT04519814
Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
A study testing selective laser trabeculoplasty (SLT) in people with Primary Open-angle Glaucoma, run by Carl Zeiss Meditec AG at 5 sites in Germany.
Trial summary
An interventional, open, prospective, multi-center pre-market clinical investigation according to §§20-23a Medizinproduktegesetz (MPG, medical devices act), in which a total of 40 eyes of 40 consecutive patients at up to five (5) clinical sites will be enrolled, treated with the VISULAS green with option CSLT, and… Read more about this study
- Who is it for?
- Ages 22 years and older
- Conditions the study is for
- Primary Open-angle Glaucoma
- What is being tested?
- selective laser trabeculoplasty (SLT)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 5 sitesGermany
- Study dates
- 30 Jun 2020to 13 Sep 2022
- 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 22 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females at least 22 years of age or older, primary open-angle glaucoma (HPG + NPG), who did not reach target pressure .
- IOP with or without medications ≥17 mmHg in the study eye
- Chamber angle Shaffer 3 and 4
- Patients must be legally competent and able to give consent and must have read, understood and signed patient information leaflet and consent to undergo SLT in one eye
- Patients are willing and able to return for follow-up examinations
- In the opinion of the investigator, the patient will be compliant and have a high probability of completing the clinical investigation and all required procedures
Who cannot join
- Corneal disease or pathology in a way that distortion of laser light in the study eye can be expected or that precludes stabilization of the cornea by the contact glass, visibility of the trabecular meshwork or transmission of laser wavelength
- Strong clouding of the anterior ocular media (e.g. the lens due to dense cataract) and the vitreous body (e.g. due to strong vitreous hemorrhage) in either eye
- Deep orbits and/or narrow palpebral fissures
- Corneal or conjunctival abnormality precluding contact lens adaptation in either eye
- History of Amblyopia in either eye
- Any contraindications to SLT in study eye.
Show all 17Show fewer
- Any kind of planned ocular surgeries during the next 3 months (for example, cataract surgery) in either eye
- Previous intraocular or corneal surgery of any kind (except cataract surgery longer than three months prior to the clinical investigation), including surgical glaucoma intervention in study eye before the clinical investigation.
- Signs of Fuchs' Dystrophy (e.g. corneal endothelial guttata) in either eye
- Active or history of Uveitis in either eye
- Congenital glaucoma in either eye
- Diabetic retinopathy or branch retinal vein occlusion with the risk to develop neovascularizations in either eye
- Heavily pigmented trabecular meshwork due to pseudoexfoliation syndrome or pigment dispersion glaucoma in either eye
- Degenerative disorders of the central nervous system if it prevents proper compliance or the ability to undergo the tests in the clinical investigation (e.g. Parkinson Disease, Alzheimer Disease, or other forms of dementia)
- History of or has a current, clinically significant major psychiatric disorder (e.g., major depressive disorder, psychosis, schizophrenia)
- Patients who are pregnant, lactating, or of child-bearing potential and not practicing a medically approved method of birth control.
- Enrollment in another drug or device study within the prior 3 months
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Germany5 sites
Klinik und Poliklinik für Augenheilkunde, TU Dresden
Dresden
Internationale Innovative Ophthalmochirurgie GbR
Düsseldorf
Augenarztpraxis am Dreiecksplatz, Kiel
Kiel
Klinik für Augenheilkunde, UK Schleswig Holstein
Kiel
Augentagesklinik Rheine
Rheine
About this study
Official title: A Prospective, Multicenter Clinical Investigation to Evaluate Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
An interventional, open, prospective, multi-center pre-market clinical investigation according to §§20-23a Medizinproduktegesetz (MPG, medical devices act), in which a total of 40 eyes of 40 consecutive patients at up to five (5) clinical sites will be enrolled, treated with the VISULAS green with option CSLT, and followed for a three months period.
The primary objective of this clinical investigation is to evaluate safety and effectiveness of SLT with the VISULAS green laser with option CSLT.
- Conditions
- Primary Open-angle Glaucoma
- Being tested
- selective laser trabeculoplasty (SLT)
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
selective laser trabeculoplasty (SLT)Procedure or surgery
Treatment will be performed on Day 0 using the VISULAS green with Option CSLT for SLT treatment and a mirror goniolens to visualize the trabecular meshwork. The initial energy level is set according to the grade of angle pigmentation and bubble formation. Approximately one hundred non-overlapping lesions will be applied in a single session to 360° of the trabecular meshwork.
| Study group | Role | What they receive |
|---|---|---|
| all eligible patients | Experimental | A total of 40 eyes in 40 consecutive patients, 22 years of age or older, with primary open-angle glaucoma (HPG + NPG), who did not reach target pressure, agree to participate in the study, and will be able to complete clinical follow-up and evaluation. Receives: Procedure: selective laser trabeculoplasty (SLT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean absolute change in intraocular pressure (IOP) compared to baseline at month 1
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 1
Measured: one (1) month
Secondary outcomes (3)
mean relative change in intraocular pressure (IOP) compared to baseline at month 1
The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 1
Measured: one (1) month
mean absolute change in intraocular pressure (IOP) compared to baseline at month 3
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 3
Measured: three (3) months
mean relative change in intraocular pressure (IOP) compared to baseline at month 3
The endpoint is the mean change in IOP (relative value, %) of the study cohort compared to baseline at month 3
Measured: three (3) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2020
- Study start30 Jun 2020
- Primary completion23 Nov 2021
- Study completion13 Sep 2022
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 Primary Open-angle 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
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carl Zeiss Meditec AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04519814
- Sponsor's protocol ID
- T1703PM
- Status last verified
- Dec 2024
- First submitted
- 22 Jul 2020
- Last updated
- 19 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Pillunat KR, Kretz FTA, Koinzer S, Ehlken C, Pillunat LE, Klabe K. Effectiveness and safety of VISULAS(R) green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation. Int Ophthalmol. 2023 Jul;43(7):2215-2224. doi: 10.1007/s10792-022-02617-7. Epub 2022 Dec 26.
PubMed 36572747
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Clinical Investigation to Evaluate Safety and Effectiveness of VISULAS Green Selective Laser Trabeculoplasty (SLT)
- ClinicalTrials.gov ID
- NCT04519814
- Acronym / sponsor ID
- T1703PM
- Conditions
- Primary Open-angle Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Carl Zeiss Meditec AGIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2020 (actual)
- Primary completion
- 23 Nov 2021 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 20 Aug 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.
An interventional, open, prospective, multi-center pre-market clinical investigation according to §§20-23a Medizinproduktegesetz (MPG, medical devices act), in which a total of 40 eyes of 40 consecutive patients at up to five (5) clinical sites will be enrolled, treated with the VISULAS green with option CSLT, and followed for a three months period.
The primary objective of this clinical investigation is to evaluate safety and effectiveness of SLT with the VISULAS green laser with option CSLT.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all eligible patients | Experimental | Procedure: selective laser trabeculoplasty (SLT)A total of 40 eyes in 40 consecutive patients, 22 years of age or older, with primary open-angle glaucoma (HPG + NPG), who did not reach target pressure, agree to participate in the study, and will be able to complete clinical follow-up and evaluation. |
Who may qualify
- Ages
- 22 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and females at least 22 years of age or older, primary open-angle glaucoma (HPG + NPG), who did not reach target pressure .
- IOP with or without medications ≥17 mmHg in the study eye
- Chamber angle Shaffer 3 and 4
- Patients must be legally competent and able to give consent and must have read, understood and signed patient information leaflet and consent to undergo SLT in one eye
- Patients are willing and able to return for follow-up examinations
Key exclusion criteria (17 listed)
- Corneal disease or pathology in a way that distortion of laser light in the study eye can be expected or that precludes stabilization of the cornea by the contact glass, visibility of the trabecular meshwork or transmission of laser wavelength
- Strong clouding of the anterior ocular media (e.g. the lens due to dense cataract) and the vitreous body (e.g. due to strong vitreous hemorrhage) in either eye
- Deep orbits and/or narrow palpebral fissures
- Corneal or conjunctival abnormality precluding contact lens adaptation in either eye
- History of Amblyopia in either eye
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 |
|---|---|---|
| selective laser trabeculoplasty (SLT)Treatment will be performed on Day 0 using the VISULAS green with Option CSLT for SLT treatment and a mirror goniolens to visualize the trabecular meshwork. The initial energy level is set according to the grade of angle pigmentation and bubble formation. Approximately one hundred non-overlapping lesions will be applied in a single session to 360° of the trabecular meshwork. | Procedure or surgery | all eligible patients |
Primary outcome
mean absolute change in intraocular pressure (IOP) compared to baseline at month 1
Time frame: one (1) month
The endpoint is the mean change in IOP (Absolute value, mmHg) of the study cohort compared to baseline at month 1
3 secondary outcomes
mean relative change in intraocular pressure (IOP) compared to baseline at month 1
Time frame: one (1) month
mean absolute change in intraocular pressure (IOP) compared to baseline at month 3
Time frame: three (3) months
mean relative change in intraocular pressure (IOP) compared to baseline at month 3
Time frame: three (3) 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 19 Dec 2024.
- Results publication: PubMed 36572747Pillunat KR, Kretz FTA, Koinzer S, Ehlken C, Pillunat LE, Klabe K. Effectiveness and safety of VISULAS(R) green selective laser trabeculoplasty: a prospective, interventional multicenter clinical investigation. Int Ophthalmol. 2023 Jul;43(7):2215-2224. doi: 10.1007/s10792-022-02617-7. Epub 2022 Dec 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing selective laser trabeculoplasty (SLT) in people with Primary Open-angle Glaucoma, run by Carl Zeiss Meditec AG at 5 sites in Germany.
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 6 inclusion and 17 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 19 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany. 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?
mean absolute change in intraocular pressure (IOP) compared to baseline at month 1 (time frame: one (1) month). 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 NCT04519814, 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 19 Dec 2024.