GlaucomaNCT06722794
Fixating the Plate of Ahmed Valve to the Sclera Using a Flanged Prolene Suture
A study testing Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture in people with Glaucoma, run by Zagazig University at 1 site in Saudi Arabia.
Trial summary
this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma 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?
- Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 1 Jun 2024to 31 Oct 2024
- 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
- Patients with IOP more than 21 mmHg , evidence of progressive optic nerve damage, retinal nerve fiber layer defects or typical glaucomatous visual field defects despite maximal tolerable medical or laser treatment are scheduled for surgery.
Who cannot join
- The exclusion criteria were as follows: patients below 18 years old, those with active uveitis and angle closure glaucoma patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture
this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma
Read the detailed description
This technique of fixating Ahmed glaucoma valve using flanged prolene suture is an safe, fast, and reproducible technique combines the benefits of fixing the plate with excellent stability with no complications of free plate techniques at the same time, decreasing both the risks of old valve plate fixation techniques and the concerns of the relative technical difficulty
- Conditions
- Glaucoma
- Being tested
- Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture
- Keywords
- Ahmed glaucoma valve, prolene, glaucoma drainage device
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene SutureProcedure or surgery
This novel technique of fixating the plate of Ahmed glaucoma valve to the sclera using a single flanged prolene suture is an efficient, safe, fast, and reproducible technique that combines the benefits of both fixing the plate providing excellent stability without the complications of free plate techniques and at the same time, minimizing both the risks of conventional old valve plate fixation techniques and the concerns of the relative technical difficulty of suturing due to the difficult access to the posterior globe
| Study group | Role | What they receive |
|---|---|---|
| Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene S | Other | Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture Receives: Procedure: Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
long term stability and plate migration
ABSENT MOVEMENT OF THE PLATE WITH NO OTHER COMPLICATIONS
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2024
- Study start1 Jun 2024
- Primary completion31 Oct 2024
- Study completion31 Oct 2024
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.
- More trials run by Zagazig UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Collaborators
- Magrabi Eye & Ear Hospital
- Responsible party
- Sponsor
- Investigators
- AHMED SAMIR, MD, Principal investigator, ZAGAZIG UNIVERSITY AND MAGHRABI EYE HOSPITALS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06722794
- Sponsor's protocol ID
- MEH-IRB# 310- 1-October-2024
- Other IDs
- Maghrabi eye hospitals
- Status last verified
- Dec 2024
- First submitted
- 2 Dec 2024
- Last updated
- 9 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: PERSONAL REASONS
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture
- ClinicalTrials.gov ID
- NCT06722794
- Acronym / sponsor ID
- MEH-IRB# 310- 1-October-2024
- Conditions
- Glaucoma
- Keywords
- Ahmed glaucoma valve, prolene, glaucoma drainage device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Collaborators
- Magrabi Eye & Ear Hospital
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 31 Oct 2024 (actual)
- Study completion
- 31 Oct 2024 (actual)
- First posted
- 9 Dec 2024 (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.
this study evaluated new technique for suturing the Ahmed valve device used to treat resistant types of glaucoma
Detailed description
This technique of fixating Ahmed glaucoma valve using flanged prolene suture is an safe, fast, and reproducible technique combines the benefits of fixing the plate with excellent stability with no complications of free plate techniques at the same time, decreasing both the risks of old valve plate fixation techniques and the concerns of the relative technical difficulty
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene S | Other | Procedure: Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene SutureNovel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with IOP more than 21 mmHg , evidence of progressive optic nerve damage, retinal nerve fiber layer defects or typical glaucomatous visual field defects despite maximal tolerable medical or laser treatment are scheduled for surgery.
Key exclusion criteria (1 listed)
- The exclusion criteria were as follows: patients below 18 years old, those with active uveitis and angle closure glaucoma patients.
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 |
|---|---|---|
| Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene SutureThis novel technique of fixating the plate of Ahmed glaucoma valve to the sclera using a single flanged prolene suture is an efficient, safe, fast, and reproducible technique that combines the benefits of both fixing the plate providing excellent stability without the complications of free plate techniques and at the same time, minimizing both the risks of conventional old valve plate fixation techniques and the concerns of the relative technical difficulty of suturing due to the difficult access to the posterior globe | Procedure or surgery | Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene S |
Primary outcome
long term stability and plate migration
Time frame: 3 months
ABSENT MOVEMENT OF THE PLATE WITH NO OTHER COMPLICATIONS
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 9 Dec 2024.
- Individual participant dataSharing planned: No. PERSONAL REASONS
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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.
AHMED SAMIR, MD principal investigator
ZAGAZIG UNIVERSITY AND MAGHRABI EYE HOSPITALS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Novel Technique for Fixating the Plate of Ahmed Valve to the Sclera Using a Single Flanged Prolene Suture in people with Glaucoma, run by Zagazig University at 1 site in Saudi Arabia.
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 1 inclusion and 1 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 9 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 1 site in Saudi Arabia. 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?
long term stability and plate migration (time frame: 3 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 9 Dec 2024.