Primary Congenital GlaucomaSTOP-GlaucomaNCT04647929
Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas
A study testing Santen PRESERFLO MicroShunt and Trabeculectomy in people with Primary Congenital Glaucoma and Developmental Glaucoma, run by University of Zurich.
Trial summary
Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Primary Congenital Glaucoma, Developmental Glaucoma
- What is being tested?
- Santen PRESERFLO MicroShunt and Trabeculectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2020to 1 Jun 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Minors younger than 18 years of age with a diagnosis of Primary Congenital Glaucoma (PCG) or Developmental Glaucoma (DG) will be included
- participants must have had a failed trabeculotomy or goniotomy (once or twice) or one 360° trabeculotomy.
Who cannot join
- Individuals with eye pathologies other than glaucoma or, who underwent intraocular surgery within the last 6 months will not be included.
- patients who will not be willing to proceed with the entire follow-up of 6 months, or whose legal representative did not sign the informed consent will not be enrolled.
About this study
Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy.
Read the detailed description
Glaucoma is a chronic, progressive disease, leading to blindness if untreated or insufficiently treated. It is characterized by a loss of optic nerve fiber and a glaucomatous optic disc excavation and, a corresponding pattern of visual field loss. Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). PCG and DG are treated surgically, either by goniotomy or by trabeculotomy as first approach, and not with topical hypotensive medications. Whenever these procedures have failed, the subsequent surgical procedure is usually trabeculectomy with Mitomycin C or the implantation of a glaucoma drainage device. However, there is a lack of evidence regarding the "optimal" surgical approach after failed goniotomy/trabeculotomy. Optimal treatment in this young group of patients with a long life expectancy is crucial to prevent blindness, allow them to participate in a "normal" school and work environment, and to minimize disease burdens for these patients and their families as well as to minimize costs for society. Consequently, there is the desire to find a procedure with a superior success rate and even fewer or less severe complications compared to trabeculectomy. Recently, the Santen PRESERFLO was introduced. The results proved fewer complications and comparable efficacy to trabeculectomy, according results presented at scientific meetings. Yet, there are no published studies to compare the both procedures. The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients.
- Being tested
- Santen PRESERFLO MicroShunt, Trabeculectomy
- Keywords
- glaucoma, primary congenital glaucoma, developmental glaucoma
- Medical subject headings
- Hydrophthalmos, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Santen PRESERFLO MicroShuntDevice
the PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow
TrabeculectomyProcedure or surgery
a fornix-based trabeculectomy with a 3x4mm flap will be performed to increase aqueous humor outflow
| Study group | Role | What they receive |
|---|---|---|
| PRESERFLO MicroShunt | Experimental | Patients will undergo Santen PRESERFLO MicroShunt implantation with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes. Receives: Device: Santen PRESERFLO MicroShunt |
| Trabeculectomy | Active comparator | Patients will undergo trabeculectomy with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes. Receives: Procedure: Trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy 1
Change in Goldmann-applanation intraocular pressure (IOP) in mmHg
Measured: at 6months compared to baseline (i.e. preop)
Efficacy 2
Change in the number of drug classes of intraocular pressure (IOP) lowering medications
Measured: at 6months compared to baseline (i.e. preop)
Complication rate
rate of intraoperative and postoperative complications (safety)
Measured: within 6 months from surgery
Secondary outcomes (1)
Exome Sequencing
for known and susprected genes for primary congenital glaucoma or developmental glaucoma as a potential confounder for outcome and rates of complications will be statistically evaluated
Measured: at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2020
- Study start1 Dec 2020 (estimated)
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Jun 2023
Why it stopped: Funding for the study could not be found.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Primary Congenital GlaucomaStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Te patients will be randomly assigned in a 1:1 ratio to either (1) Santen PRESERFLO implant (intervention arm) or (2) trabeculectomy (standard therapy) .
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Responsible party
- Sponsor
- Investigators
- - Individuals with eye pathologies other than glaucoma or, who Töteberg-Harms, MD, FEBO, Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04647929
- Sponsor's protocol ID
- STOP Glaucoma
- Acronym
- STOP-Glaucoma
- Status last verified
- Jun 2023
- First submitted
- 16 Nov 2020
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque R, Kato YP, Arrieta E, Peralta AC, Palmberg P, Parrish RK 2nd, Weber BA, Parel JM. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma. 2016 Feb;25(2):e58-65. doi: 10.1097/IJG.0000000000000368.
PubMed 26766400Jayaram H, Scawn R, Pooley F, Chiang M, Bunce C, Strouthidis NG, Khaw PT, Papadopoulos M. Long-Term Outcomes of Trabeculectomy Augmented with Mitomycin C Undertaken within the First 2 Years of Life. Ophthalmology. 2015 Nov;122(11):2216-22. doi: 10.1016/j.ophtha.2015.07.028. Epub 2015 Aug 24.
PubMed 26315044
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Surgical Treatment Options for Primary Congenital and Developmental Glaucomas
- ClinicalTrials.gov ID
- NCT04647929
- Acronym / sponsor ID
- STOP-Glaucoma / STOP Glaucoma
- Keywords
- glaucoma, primary congenital glaucoma, developmental glaucoma
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Funding for the study could not be found.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Johannes Gutenberg University Mainz
- Study start
- 1 Dec 2020 (estimated)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Jun 2023 (actual)
- First posted
- 1 Dec 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.
Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients as second surgery after failed trabeculotomy or goniotomy.
Detailed description
Glaucoma is a chronic, progressive disease, leading to blindness if untreated or insufficiently treated. It is characterized by a loss of optic nerve fiber and a glaucomatous optic disc excavation and, a corresponding pattern of visual field loss. Newborn and children can be affected by two subgroups of this disease: (1) primary congenital glaucoma (PCG) or (2) developmental glaucoma (DG). PCG and DG are treated surgically, either by goniotomy or by trabeculotomy as first approach, and not with topical hypotensive medications. Whenever these procedures have failed, the subsequent surgical procedure is usually trabeculectomy with Mitomycin C or the implantation of a glaucoma drainage device. However, there is a lack of evidence regarding the "optimal" surgical approach after failed goniotomy/trabeculotomy. Optimal treatment in this young group of patients with a long life expectancy is crucial to prevent blindness, allow them to participate in a "normal" school and work environment, and to minimize disease burdens for these patients and their families as well as to minimize costs for society. Consequently, there is the desire to find a procedure with a superior success rate and even fewer or less severe complications compared to trabeculectomy. Recently, the Santen PRESERFLO was introduced. The results proved fewer complications and comparable efficacy to trabeculectomy, according results presented at scientific meetings. Yet, there are no published studies to compare the both procedures. The primary aim of this study is to compare the Santen PRESERFLO implant to trabeculectomy in PCG and DG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Te patients will be randomly assigned in a 1:1 ratio to either (1) Santen PRESERFLO implant (intervention arm) or (2) trabeculectomy (standard therapy) .
| Arm | Type | Receives |
|---|---|---|
| PRESERFLO MicroShunt | Experimental | Device: Santen PRESERFLO MicroShuntPatients will undergo Santen PRESERFLO MicroShunt implantation with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes. |
| Trabeculectomy | Active comparator | Procedure: TrabeculectomyPatients will undergo trabeculectomy with intraoperative use of Mitomycin C 0.2mg/ml for 2 minutes. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Minors younger than 18 years of age with a diagnosis of Primary Congenital Glaucoma (PCG) or Developmental Glaucoma (DG) will be included
- participants must have had a failed trabeculotomy or goniotomy (once or twice) or one 360° trabeculotomy.
Key exclusion criteria (2 listed)
- Individuals with eye pathologies other than glaucoma or, who underwent intraocular surgery within the last 6 months will not be included.
- patients who will not be willing to proceed with the entire follow-up of 6 months, or whose legal representative did not sign the informed consent will not be enrolled.
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 |
|---|---|---|
| Santen PRESERFLO MicroShuntthe PRESERFLO MicroShunt will be implanted to increase aqueous humor outflow | Device | PRESERFLO MicroShunt |
| Trabeculectomya fornix-based trabeculectomy with a 3x4mm flap will be performed to increase aqueous humor outflow | Procedure or surgery | Trabeculectomy |
Primary outcome
Efficacy 1
Time frame: at 6months compared to baseline (i.e. preop)
Change in Goldmann-applanation intraocular pressure (IOP) in mmHg
Efficacy 2
Time frame: at 6months compared to baseline (i.e. preop)
Change in the number of drug classes of intraocular pressure (IOP) lowering medications
Complication rate
Time frame: within 6 months from surgery
rate of intraoperative and postoperative complications (safety)
1 secondary outcome
Exome Sequencing
Time frame: at baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Results publication: PubMed 26766400Batlle JF, Fantes F, Riss I, Pinchuk L, Alburquerque R, Kato YP, Arrieta E, Peralta AC, Palmberg P, Parrish RK 2nd, Weber BA, Parel JM. Three-Year Follow-up of a Novel Aqueous Humor MicroShunt. J Glaucoma. 2016 Feb;25(2):e58-65. doi: 10.1097/IJG.0000000000000368.
- Results publication: PubMed 26315044Jayaram H, Scawn R, Pooley F, Chiang M, Bunce C, Strouthidis NG, Khaw PT, Papadopoulos M. Long-Term Outcomes of Trabeculectomy Augmented with Mitomycin C Undertaken within the First 2 Years of Life. Ophthalmology. 2015 Nov;122(11):2216-22. doi: 10.1016/j.ophtha.2015.07.028. Epub 2015 Aug 24.
- Individual participant dataSharing planned: No
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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.
- Individuals with eye pathologies other than glaucoma or, who Töteberg-Harms, MD, FEBO principal investigator
University of Zurich
Questions about this trial
What is this clinical trial studying?
A study testing Santen PRESERFLO MicroShunt and Trabeculectomy in people with Primary Congenital Glaucoma and Developmental Glaucoma, run by University of Zurich.
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 2 inclusion and 2 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: withdrawn, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Efficacy 1 (time frame: at 6months compared to baseline (i.e. preop)). The study lists 3 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 NCT04647929, which also lists 2 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 5 Jun 2023.