Glaucoma, Angle-ClosureNCT06445634
Outcome of GATT Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure.
A study testing Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in people with Glaucoma, Angle-Closure, run by Kasr El Aini Hospital at 1 site in Egypt.
Trial summary
To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma, Angle-Closure
- What is being tested?
- Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2024to 1 Aug 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with secondary synechial angle closure glaucoma
- Involving more than 180 degrees of the iridocorneal angle
- Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.
Who cannot join
- Eyes with PACG.
- Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).
- Eyes with retinal pathology.
- Eyes requiring combined phacoemulsification and GATT.
- Eyes with corneal pathology that can preclude surgery and imaging.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasralainy Hospitals
Giza, 11555
Rokaya Radwan, 01066471468 ext. +2, rokaia.e.radwan@students.kasralainy.edu.eg
About this study
Official title: Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure: A Prospective Case Series
To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.
Read the detailed description
Glaucoma is a group of diseases that present with cupping of the optic nerve head and visual-field defects. It is the most common cause of irreversible blindness all over the world.Angle-closure glaucoma is a type of glaucoma characterized by narrowing or closure of the anterior chamber angle.
Two major types of angle closure glaucoma are defined by the mechanism of angle closure: in appositional contact, the iris is pushed by a pressure difference between the posterior and anterior chambers due to relative pupillary block, while in synechial contact, the peripheral iris adheres to the trabecular meshwork by peripheral anterior synechiae (PAS). PAS can develop in various ocular conditions, including: ocular inflammation, a post-traumatic condition, after cataract surgery, or with an iris bombe in a pupillary block glaucoma.
Grover et al. described a technique for ab-Interno circumferential trabeculotomy termed gonioscopy-assisted transluminal trabeculotomy (GATT). The procedure aims to create a 360° trabeculotomy from an ab-Interno approach.
GATT procedure is a MIGS technique in which trabecular meshwork is circumferentially bypassed by incising it using a suture or microcatheter.In this technique, aqueous humor passes through the collector channels and episcleral veins through the cleaved open diseased trabecular meshwork.
Elsayed et al previously demonstrated that combining phacoemulsification with GATT in PACG yielded more favorable outcomes in terms of IOP, glaucoma medications and surgical success compared to phacoemulsification alone.However, to date, no studies have looked at the outcomes of combining goniosynechialysis with GATT in secondary angle closure glaucoma. In fact, most studies looking at the outcomes of GATT in different types of glaucoma excluded eyes with synechial angle closure.
Goniosynechialysis (GSL) is the process of physically separating PAS, which can develop in the trabecular meshwork due to various conditions including primary and secondary cases of angle closure.
So, for those cases of synechial angle closure glaucoma combining GATT and GSL might aid in the IOP lowering effect required.
- Conditions
- Glaucoma, Angle-Closure
- Being tested
- Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis
- Keywords
- secodary angle closure, GATT, intra ocular pressure
- Medical subject headings
- Glaucoma, Angle-Closure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonioscopy-Assisted Transluminal Trabeculotomy Combined with GoniosynechiolysisOther
Also called GATT
Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure
| Study group | Role | What they receive |
|---|---|---|
| Gatt combined with goinosynechiolysis in secondary synechial angle closure | Other | Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure Receives: Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP and glaucoma medications.
measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative
Measured: 1day,1 week,1 months, 3 months, 6 months and 1 year
Surgical success.
Surgical success will be defined as: complete if IOP is less than or equal to 21mmHg without medications and qualified success if IOP is less than or equal to 21mmHg with medications. Failure will be the inability to achieve such a pressure, the need for another glaucoma operation or the development of a sight-threatening complication (e.g., retinal detachment, endophthalmitis)
Measured: 1day,1 week,1 months, 3 months, 6 months and 1 year
Secondary outcomes (1)
Complications.
rate of complications will be recorded
Measured: 1day,1 week,1 months, 3 months, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2024
- Study start1 Apr 2024
- Primary completion1 Aug 2025 (estimated)
- Study completion1 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Angle-ClosureStudies 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
- Model description
- prospective cohort
- Masking
- None (open label)
- Enrolment
- 23 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rokaya Emad Radwan, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06445634
- Sponsor's protocol ID
- _MD-393-2023_
- Status last verified
- Jun 2024
- First submitted
- 31 May 2024
- Last updated
- 6 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined With Goniosynechiolysis in Glaucoma Patients With Secondary Synechial Angle Closure: A Prospective Case Series
- ClinicalTrials.gov ID
- NCT06445634
- Acronym / sponsor ID
- _MD-393-2023_
- Conditions
- Glaucoma, Angle-Closure
- Keywords
- secodary angle closure, GATT, intra ocular pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 23 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 1 Aug 2025 (estimated)
- Study completion
- 1 Aug 2025 (estimated)
- First posted
- 6 Jun 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.
To evaluate the intraocular pressure reduction effect of combined gonioscopy-assisted transluminal trabeculotomy (GATT) with goniosynechialysis in eyes with secondary synechial angle closure glaucoma.
Detailed description
Glaucoma is a group of diseases that present with cupping of the optic nerve head and visual-field defects. It is the most common cause of irreversible blindness all over the world.Angle-closure glaucoma is a type of glaucoma characterized by narrowing or closure of the anterior chamber angle.
Two major types of angle closure glaucoma are defined by the mechanism of angle closure: in appositional contact, the iris is pushed by a pressure difference between the posterior and anterior chambers due to relative pupillary block, while in synechial contact, the peripheral iris adheres to the trabecular meshwork by peripheral anterior synechiae (PAS). PAS can develop in various ocular conditions, including: ocular inflammation, a post-traumatic condition, after cataract surgery, or with an iris bombe in a pupillary block glaucoma.
Grover et al. described a technique for ab-Interno circumferential trabeculotomy termed gonioscopy-assisted transluminal trabeculotomy (GATT). The procedure aims to create a 360° trabeculotomy from an ab-Interno approach.
GATT procedure is a MIGS technique in which trabecular meshwork is circumferentially bypassed by incising it using a suture or microcatheter.In this technique, aqueous humor passes through the collector channels and episcleral veins through the cleaved open diseased trabecular meshwork.
Elsayed et al previously demonstrated that combining phacoemulsification with GATT in PACG yielded more favorable outcomes in terms of IOP, glaucoma medications and surgical success compared to phacoemulsification alone.However, to date, no studies have looked at the outcomes of combining goniosynechialysis with GATT in secondary angle closure glaucoma. In fact, most studies looking at the outcomes of GATT in different types of glaucoma excluded eyes with synechial angle closure.
Goniosynechialysis (GSL) is the process of physically separating PAS, which can develop in the trabecular meshwork due to various conditions including primary and secondary cases of angle closure.
So, for those cases of synechial angle closure glaucoma combining GATT and GSL might aid in the IOP lowering effect required.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective cohort
| Arm | Type | Receives |
|---|---|---|
| Gatt combined with goinosynechiolysis in secondary synechial angle closure | Other | Other: Gonioscopy-Assisted Transluminal Trabeculotomy Combined with GoniosynechiolysisOutcome of Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with secondary synechial angle closure glaucoma
- Involving more than 180 degrees of the iridocorneal angle
- Requiring surgery for uncontrolled IOP despite maximum tolerated therapy.
Key exclusion criteria (5 listed)
- Eyes with PACG.
- Eyes with neovascular glaucoma. (Some apparently stable NVG cases would have remnants of neo-vessels in the angle that are hidden behind the synechiae).
- Eyes with retinal pathology.
- Eyes requiring combined phacoemulsification and GATT.
- Eyes with corneal pathology that can preclude surgery and imaging.
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 |
|---|---|---|
| Gonioscopy-Assisted Transluminal Trabeculotomy Combined with GoniosynechiolysisAlso: GATTGonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in Glaucoma Patients with Secondary Synechial Angle Closure | Other | Gatt combined with goinosynechiolysis in secondary synechial angle closure |
Primary outcome
IOP and glaucoma medications.
Time frame: 1day,1 week,1 months, 3 months, 6 months and 1 year
measurement of intra ocular pressure and documentation of number of anti glaucoma medications post operative
Surgical success.
Time frame: 1day,1 week,1 months, 3 months, 6 months and 1 year
Surgical success will be defined as: complete if IOP is less than or equal to 21mmHg without medications and qualified success if IOP is less than or equal to 21mmHg with medications. Failure will be the inability to achieve such a pressure, the need for another glaucoma operation or the development of a sight-threatening complication (e.g., retinal detachment, endophthalmitis)
1 secondary outcome
Complications.
Time frame: 1day,1 week,1 months, 3 months, 6 months and 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2024.
- Individual participant dataSharing planned: Yes. medical data including intraocular pressure and study outcomes will be shared but excluding any participant confidential data
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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?
A study testing Gonioscopy-Assisted Transluminal Trabeculotomy Combined with Goniosynechiolysis in people with Glaucoma, Angle-Closure, run by Kasr El Aini Hospital at 1 site in Egypt.
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 3 inclusion and 5 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 6 Jun 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 Egypt. 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 Rokaya Radwan (01066471468 ext. +2, rokaia.e.radwan@students.kasralainy.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP and glaucoma medications. (time frame: 1day,1 week,1 months, 3 months, 6 months and 1 year). The study lists 2 primary outcomes in all. 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 6 Jun 2024.