Angle Glaucoma OpenNCT05932940
Incidence of Descemet Membrane Detachment Post GATT by AS OCT
A study testing Gonioscopy-Assisted Transluminal Trabeculotomy in people with Angle Glaucoma Open, run by Cairo University at 1 site in Egypt.
Trial summary
detection of Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Angle Glaucoma Open
- What is being tested?
- Gonioscopy-Assisted Transluminal Trabeculotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2022to 10 May 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 70 years.
- Patients with open angle glaucoma undergoing gonioscopy assisted transluminal trabeculotomy.
Who cannot join
- Patients with with open angle glaucoma and aphakia.
- Patients with Congenital Glaucoma.
- Patients with open angle glaucoma undergoing phaco -gonioscopy-assisted transluminal trabeculotomy.
- Patients with neovascular glaucoma.
- Patients with pigmentary Glaucoma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Descemet Membrane Detachment Post Gonioscopy-Assisted Transluminal Trabeculotomy by Anterior Segment Optical Coherence Tomography in Patients With Open Angle Glaucoma
detection of Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Read the detailed description
In our study, which should include 30 eyes with OAG who underwent 360 GATT Screening for Descemet Membrane Detachment will be done by Anterior Segment Optical coherence Tomography using SD-OCT: Optovue RTVue (Optovue Inc., Fremont, CA, USA) for the angle day 1 post operative for all patients and 1 week post operative in cases with Descemet membrane detachment to check for spontaneous resolution.
One month post-operative the patients underwent
- Best corrected visual acuity (BCVA) using decimal.
- IOP measurement using GAT.
- Conditions
- Angle Glaucoma Open
- Being tested
- Gonioscopy-Assisted Transluminal Trabeculotomy
- Keywords
- gonioscopy-assisted transluminal trabeculotomy, Descemet membrane detachment
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gonioscopy-Assisted Transluminal TrabeculotomyProcedure or surgery
Ab interno angle surgery one of MIGS to lower IOP
| Study group | Role | What they receive |
|---|---|---|
| GATT group | Experimental | detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma. Receives: Procedure: Gonioscopy-Assisted Transluminal Trabeculotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Descemet Membrane detachment post GATT
Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy
Measured: 4 months
Secondary outcomes (3)
Amount of reduction of IOP and Glaucoma NGM
Amount of reduction of intraocular pressure and Number of Glaucoma medications
Measured: 4 months
Incidence of Hyphema post GATT
Incidence of Hyphema post Gonioscopy-Assisted Transluminal Trabeculotomy
Measured: 4 months
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start1 Dec 2022
- Primary completion1 Mar 2024
- Study completion10 May 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Glaucoma OpenStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Elsayed Soliman Ahmed, Cairo University
- Investigators
- Fayrouz Aboalazayem, phD, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932940
- Sponsor's protocol ID
- MS-275-2022
- Status last verified
- Mar 2024
- First submitted
- 7 May 2023
- Last updated
- 15 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Descemet Membrane Detachment Post Gonioscopy-Assisted Transluminal Trabeculotomy by Anterior Segment Optical Coherence Tomography in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05932940
- Acronym / sponsor ID
- MS-275-2022
- Conditions
- Angle Glaucoma Open
- Keywords
- gonioscopy-assisted transluminal trabeculotomy, Descemet membrane detachment
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 10 May 2024 (estimated)
- First posted
- 6 Jul 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.
detection of Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Detailed description
In our study, which should include 30 eyes with OAG who underwent 360 GATT Screening for Descemet Membrane Detachment will be done by Anterior Segment Optical coherence Tomography using SD-OCT: Optovue RTVue (Optovue Inc., Fremont, CA, USA) for the angle day 1 post operative for all patients and 1 week post operative in cases with Descemet membrane detachment to check for spontaneous resolution.
One month post-operative the patients underwent
- Best corrected visual acuity (BCVA) using decimal.
- IOP measurement using GAT.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- detection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
| Arm | Type | Receives |
|---|---|---|
| GATT group | Experimental | Procedure: Gonioscopy-Assisted Transluminal Trabeculotomydetection of incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 - 70 years.
- Patients with open angle glaucoma undergoing gonioscopy assisted transluminal trabeculotomy.
Key exclusion criteria (5 listed)
- Patients with with open angle glaucoma and aphakia.
- Patients with Congenital Glaucoma.
- Patients with open angle glaucoma undergoing phaco -gonioscopy-assisted transluminal trabeculotomy.
- Patients with neovascular glaucoma.
- Patients with pigmentary Glaucoma.
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 TrabeculotomyAb interno angle surgery one of MIGS to lower IOP | Procedure or surgery | GATT group |
Primary outcome
Incidence of Descemet Membrane detachment post GATT
Time frame: 4 months
Incidence of Descemet membrane Detachment post Gonioscopy-Assisted Transluminal Trabeculotomy
3 secondary outcomes
Amount of reduction of IOP and Glaucoma NGM
Time frame: 4 months
Incidence of Hyphema post GATT
Time frame: 4 months
Incidence of Descemet membrane detachment post gonioscopy-assisted transluminal trabeculotomy by anterior segment optical coherence tomography in patients with open angle glaucoma.
Time frame: 4 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2024.
- 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.
Fayrouz Aboalazayem, phD principal investigator
Cairo University
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 in people with Angle Glaucoma Open, run by Cairo University 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 2 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 15 Mar 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?
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?
Incidence of Descemet Membrane detachment post GATT (time frame: 4 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 15 Mar 2024.