GlaucomaNCT04586738
Efficacy and Safety of Non-resorbable Uveoscleral Implant Versus Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy
A study testing non-perforating deep sclerectomy surgery in people with Glaucoma, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
Trial summary
The aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- non-perforating deep sclerectomy surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Sep 2020to Dec 2021
- 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 older than 18 years of age
- Primary or secondary open-angle glaucoma
- High intraocular pressure (greater than or equal to 18mmHg) despite using maximum medical treatment
- Intolerance to medication.
Who cannot join
- Patients with previous glaucoma surgery
- Previous ocular surgery in the last 6 months
- Previous history of Laser trabeculoplasty in the last 12 months
- Moderate or severe diabetic retinopathy
- Active or recurrent eye disease (uveitis)
- Plateau iris
Show all 12Show fewer
- Ocular neovascularization
- Aphakia
- Neovascular angle-closure glaucoma
- Previous history of intraocular or extraocular malignant neoplasm
- Pregnancy or lactation period, axial length> 26mm and <20mm
- Unwillingness for participating
Trial locations and contacts
2 sites in 1 country.
Spain2 sites, 2 recruiting
- Recruiting
Jéssica Botella García
Barcelona, 08391
Jéssica Botella, 691801518, Jessicabotga@gmail.com
- Recruiting
Hospital Universitario Germans Trias i Pujol
Barcelona
Jéssica B García, 691801518, Jessicabotga@gmail.com
About this study
Official title: Comparative Clinical Trial on the Efficacy and Safety of Non-resorbable Uveoscleral Implant Associated With Absorbable Collagen Matrix vs Isolated Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy in Glaucoma Surgery
The aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
Read the detailed description
The aim of this study is to evaluate and compare the hypotensive efficacy at 24 months between two implants in glaucoma surgery. Non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
- Conditions
- Glaucoma
- Being tested
- non-perforating deep sclerectomy surgery
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-perforating deep sclerectomy surgeryProcedure or surgery
Non-penetrating deep sclerectomy is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma.This surgery is performed to facilitate the outflow of aqueous humour from the anterior chamber to the subconjunctival space through a natural membrane (trabeculo-Descemet's window). This enables a more physiological reduction of intraocular pressure to be achieved.
| Study group | Role | What they receive |
|---|---|---|
| Non-resorbable uveoscleral implant associated with absorbable collagen matrix | Other | non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix Receives: Procedure: non-perforating deep sclerectomy surgery |
| Isolated absorbable collagen matrix implant | Other | non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant Receives: Procedure: non-perforating deep sclerectomy surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Intraocular pressure
Comparison of intraocular pressure measurements
Measured: 24 hours after surgery, 3 months, 12 months, 24 months
Secondary outcomes (1)
Number of adverse events
Adverse events spontaneous by subject (Safety and tolerability)
Measured: 24 hours after surgery, 3 months, 12 months, 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2020
- Study start1 Sep 2020
- Primary completionNov 2021 (estimated)
- Study completionDec 2021 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jéssica Botella García, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04586738
- Sponsor's protocol ID
- Implants in deep sclerectomy
- Status last verified
- Feb 2021
- First submitted
- 7 Oct 2020
- Last updated
- 18 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Clinical Trial on the Efficacy and Safety of Non-resorbable Uveoscleral Implant Associated With Absorbable Collagen Matrix vs Isolated Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy in Glaucoma Surgery
- ClinicalTrials.gov ID
- NCT04586738
- Acronym / sponsor ID
- Implants in deep sclerectomy
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 14 Oct 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 aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
Detailed description
The aim of this study is to evaluate and compare the hypotensive efficacy at 24 months between two implants in glaucoma surgery. Non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non-resorbable uveoscleral implant associated with absorbable collagen matrix | Other | Procedure: non-perforating deep sclerectomy surgerynon-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix |
| Isolated absorbable collagen matrix implant | Other | Procedure: non-perforating deep sclerectomy surgerynon-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 18 years of age
- Primary or secondary open-angle glaucoma
- High intraocular pressure (greater than or equal to 18mmHg) despite using maximum medical treatment
- Intolerance to medication.
Key exclusion criteria (12 listed)
- Patients with previous glaucoma surgery
- Previous ocular surgery in the last 6 months
- Previous history of Laser trabeculoplasty in the last 12 months
- Moderate or severe diabetic retinopathy
- Active or recurrent eye disease (uveitis)
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 |
|---|---|---|
| non-perforating deep sclerectomy surgeryNon-penetrating deep sclerectomy is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma.This surgery is performed to facilitate the outflow of aqueous humour from the anterior chamber to the subconjunctival space through a natural membrane (trabeculo-Descemet's window). This enables a more physiological reduction of intraocular pressure to be achieved. | Procedure or surgery | Isolated absorbable collagen matrix implant, Non-resorbable uveoscleral implant associated with absorbable collagen matrix |
Primary outcome
Number of Intraocular pressure
Time frame: 24 hours after surgery, 3 months, 12 months, 24 months
Comparison of intraocular pressure measurements
1 secondary outcome
Number of adverse events
Time frame: 24 hours after surgery, 3 months, 12 months, 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2021.
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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.
Jéssica Botella García, MD principal investigator
Germans Trias i Pujol Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non-perforating deep sclerectomy surgery in people with Glaucoma, run by Germans Trias i Pujol Hospital at 2 sites in Spain.
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 4 inclusion and 12 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 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. 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 Jéssica Botella García, MD (+34691801518, Jessicabotga@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Intraocular pressure (time frame: 24 hours after surgery, 3 months, 12 months, 24 months). 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 18 Feb 2021.