Glaucoma, Open-AngleNCT06154330
Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
An observational study of Glaucoma, Open-Angle and Suprachoroidal Space, run by Davinci LTD at 1 site in Georgia.
Trial summary
To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas. Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Glaucoma, Open-Angle, Suprachoroidal Space, Pseudo Exfoliation Syndrome
- How many people
- 91 participants
- Where
- 1 siteGeorgia
- Study dates
- 20 Nov 2023to 23 Dec 2023
- Phase
- Observational
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All study patients were Caucasian
Who may be able to join
- Male or female subjects from 40 years up to 90 years old
- Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma
- Subject is able to understand and sign a written informed consent form
- Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up
Who cannot join
- Close angle forms of glaucoma
- Congenital or developmental glaucoma
- Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL)
- Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts
- History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye
- Chronic ocular inflammatory disease, or clinically significant ocular inflammation or infection (e.g., uveitis, iritis, iridocyclitis, retinitis).
- Any condition that, in the Investigator´s opinion, can interfere with full participation in the study, including study treatment and attending required visits; can pose a significant risk to the participant, or interfere with interpretation of study data.
Trial locations and contacts
1 site in 1 country.
Georgia1 site, 1 recruiting
- Recruiting
Davinci Eye Center, LTD
Tbilisi, 0160
Nikoloz Labauri, MD. FVRS, 599003744 ext. +995, nlabauri@yahoo.com
About this study
To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.
- Keywords
- MIGS, Suprachoroidal Space, Glaucoma, Open-Angle, Suprachoroidal Silicone Tube, Suprachoroidal Shunt, Glaucoma Shunt
- Medical subject headings
- Glaucoma, Open-Angle, Choroidal Effusions, Exfoliation Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Main outcome measures
A successful outcome was defined as Intraocular Pressure (IOP) reduction in ≥20%, with the IOP range 5-21mm/Hg. Successful outcomes were further categorized into two groups: Complete success - IOP reduction in ≥20%, with unmedicated the IOP range 5-21mm/Hg and Qualified success where reduction and ranges of IOP is the same but with antiglaucoma medications. Failure was defined as IOP reduction in <20% or IOP >21mm/Hg at last follow up. Permanent hypotony was defined as IOP < 5mm/Hg during more than 4 weeks.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2023
- Study start20 Nov 2023
- Primary completion20 Dec 2023 (estimated)
- Study completion23 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-AngleStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 91 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Davinci LTD
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nikoloz Labauri, Davinci LTD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06154330
- Sponsor's protocol ID
- SCS_001
- Status last verified
- Nov 2023
- First submitted
- 23 Nov 2023
- Last updated
- 4 Dec 2023
- 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 4 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Suprachoroidal Tube Shunt in Patients With Primary Open and Pseudoexfoliation Glaucomas
- ClinicalTrials.gov ID
- NCT06154330
- Acronym / sponsor ID
- SCS_001
- Keywords
- MIGS, Suprachoroidal Space, Glaucoma, Open-Angle, Suprachoroidal Silicone Tube, Suprachoroidal Shunt, Glaucoma Shunt
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 91 participants (estimated)
- Lead sponsor
- Davinci LTDUniversity, hospital or other
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 20 Dec 2023 (estimated)
- Study completion
- 23 Dec 2023 (estimated)
- First posted
- 4 Dec 2023 (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.
To assess safety and efficacy of a novel suprachoroidal silicone tube (SST) shunt for the treatment of primary open angle and exfoliative glaucomas.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All study patients were Caucasian
Key inclusion criteria (4 listed)
- Male or female subjects from 40 years up to 90 years old
- Diagnosis of primary open angle glaucoma (POAG) and pseudo-exfoliative glaucoma
- Subject is able to understand and sign a written informed consent form
- Subject who underwent SST implantation and agreed to come for the cross-sectional follow-up
Key exclusion criteria (7 listed)
- Close angle forms of glaucoma
- Congenital or developmental glaucoma
- Pseudophakic with an anterior chamber intraocular lens (IOL), iris fixed IOL, or implantable contact lens (ICL)
- Prior glaucoma procedures such as Selective Laser Trabeculoplasty (SLT), Microinvasive Glaucoma Surgery (MIGS) or Episcleral Shunts
- History of corneal transplant, corneal refractive surgery, corneal dystrophy, or corneal ectasia (such as either keratoconus or keratoglobus) in the study eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main outcome measures
Time frame: 1 month
A successful outcome was defined as Intraocular Pressure (IOP) reduction in ≥20%, with the IOP range 5-21mm/Hg. Successful outcomes were further categorized into two groups: Complete success - IOP reduction in ≥20%, with unmedicated the IOP range 5-21mm/Hg and Qualified success where reduction and ranges of IOP is the same but with antiglaucoma medications. Failure was defined as IOP reduction in <20% or IOP >21mm/Hg at last follow up. Permanent hypotony was defined as IOP < 5mm/Hg during more than 4 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2023.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, Open-Angle and Suprachoroidal Space, run by Davinci LTD at 1 site in Georgia.
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 7 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 4 Dec 2023. 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 Georgia. 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 Nikoloz Labauri, MD. FVRS (599003744 ext. +995, nlabauri@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main outcome measures (time frame: 1 month). 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 4 Dec 2023.