Glaucoma PediatricUBMNCT05530031
UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma
A study testing trabeculotomy ( angle glaucoma surgery ) in people with Glaucoma Pediatric, run by Mansoura University at 1 site in Egypt.
Trial summary
Different types of surgery are applied in PCG, including goniotomy, trabeculotomy, glaucoma drainage devices and trabeculectomy. UBM examination of the anterior chamber before surgery can help in the decision to what type of surgery is best for the patient. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Glaucoma Pediatric
- What is being tested?
- trabeculotomy ( angle glaucoma surgery )
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2022to Jun 2023
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma
Who cannot join
- patients refusing the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Dina Abd Elfattah
Al Mansurah, Dakahlia Governorate, 35100
Dina Abd Elfattah, MD, +201001951177 ext. +2, dinaabdelfattah@mans.edu.eg
About this study
Different types of surgery are applied in PCG, including goniotomy, trabeculotomy, glaucoma drainage devices and trabeculectomy. UBM examination of the anterior chamber before surgery can help in the decision to what type of surgery is best for the patient. Aim of the work To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.
Read the detailed description
To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma Methods
History taking:
- Family history of ocular pathologies or syndromes.
- Age at which the mother noticed ocular affection, time and type of intervention.
- Onset of IOP elevation, IOP lowering medications used and any previous surgical intervention for glaucoma.
Preoperative examination \& assessment
- Examination under anaesthesia for state of the conjunctiva, conreal incision scars, corneal diameter, Haab's stria, broad limbus, anterior chamber depth, regularity and content, pupil shape, centration and response to mydriatics, IOL position and status in pseudophakic cases, IOP value, optic nerve cupping.
- A scan for axial length and central corneal thickness.
- B scan ultrasonography.
- UBM : full detailed anterior segment examination will be done including : trabecular iris angle width , presence of abnormal iris insertion , abnormal membranes , Schlemm canal studying and iris thickness. All these parameters will be recorded for all 4 quadrants to select the most appropriate site of trabeculotomy.
Procedure
- trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
Follow up
- Postoperative visits planned on the first day, first week, second week, at first month, three months and six months.
- Outcome measures included the IOP value at each visit, corneal diameters, cup disc ratio if accessible, the number of glaucoma medications used, the number and kind of complications.
- Surgical success was defined as:
- Complete sucess when IOP >5mmHg and ≤21mmHg or 30% IOP reduction from baseline and without any further IOP-lowering surgery.
- Qualitative success when IOP ≤21mmHg or 30% IOP reduction from baseline but with the use of IOP lowering medications.
- Failure is defined as:
- IOP more than 21mmHg despite the use of IOP lowering medications.
- Hypotony: IOP ≤5mmHg persistent for more than two weeks.
- Need for other glaucoma surgery to control IOP.
- Conditions
- Glaucoma Pediatric
- Being tested
- trabeculotomy ( angle glaucoma surgery )
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trabeculotomy ( angle glaucoma surgery )Procedure or surgery
a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
| Study group | Role | What they receive |
|---|---|---|
| pediatric glaucoma patients either primary or secondary | Experimental | All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma Receives: Procedure: trabeculotomy ( angle glaucoma surgery ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure
success of glaucoma surgery
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study startSep 2022 (estimated)
- Primary completionJan 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma PediatricStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- • trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina abdelfattah, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530031
- Sponsor's protocol ID
- R.22.09.1801
- Acronym
- UBM
- Status last verified
- Sep 2022
- First submitted
- 3 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: results
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UBM Guided Site and Extent of Trabeculotomy in Pediatric Glaucoma
- ClinicalTrials.gov ID
- NCT05530031
- Acronym / sponsor ID
- UBM / R.22.09.1801
- Conditions
- Glaucoma Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Sep 2022 (estimated)
- Primary completion
- Jan 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 7 Sep 2022 (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.
Different types of surgery are applied in PCG, including goniotomy, trabeculotomy, glaucoma drainage devices and trabeculectomy. UBM examination of the anterior chamber before surgery can help in the decision to what type of surgery is best for the patient. Aim of the work To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.
Detailed description
To study the value of using UBM to select the site and extent of trabeculotomy in pediatric glaucoma and its correlation with surgical outcomes.All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma Methods
History taking:
- Family history of ocular pathologies or syndromes.
- Age at which the mother noticed ocular affection, time and type of intervention.
- Onset of IOP elevation, IOP lowering medications used and any previous surgical intervention for glaucoma.
Preoperative examination \& assessment
- Examination under anaesthesia for state of the conjunctiva, conreal incision scars, corneal diameter, Haab's stria, broad limbus, anterior chamber depth, regularity and content, pupil shape, centration and response to mydriatics, IOL position and status in pseudophakic cases, IOP value, optic nerve cupping.
- A scan for axial length and central corneal thickness.
- B scan ultrasonography.
- UBM : full detailed anterior segment examination will be done including : trabecular iris angle width , presence of abnormal iris insertion , abnormal membranes , Schlemm canal studying and iris thickness. All these parameters will be recorded for all 4 quadrants to select the most appropriate site of trabeculotomy.
Procedure
- trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
Follow up
- Postoperative visits planned on the first day, first week, second week, at first month, three months and six months.
- Outcome measures included the IOP value at each visit, corneal diameters, cup disc ratio if accessible, the number of glaucoma medications used, the number and kind of complications.
- Surgical success was defined as:
- Complete sucess when IOP >5mmHg and ≤21mmHg or 30% IOP reduction from baseline and without any further IOP-lowering surgery.
- Qualitative success when IOP ≤21mmHg or 30% IOP reduction from baseline but with the use of IOP lowering medications.
- Failure is defined as:
- IOP more than 21mmHg despite the use of IOP lowering medications.
- Hypotony: IOP ≤5mmHg persistent for more than two weeks.
- Need for other glaucoma surgery to control IOP.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- • trabeculotomy (with Metal Trabeculotome): a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema.
| Arm | Type | Receives |
|---|---|---|
| pediatric glaucoma patients either primary or secondary | Experimental | Procedure: trabeculotomy ( angle glaucoma surgery )All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- All Cases with pediatric glaucoma prepared for trabeculotomy including Primary congenital glaucoma and secondary glaucoma as : glaucoma following cataract surgery and traumatic glaucoma
Key exclusion criteria (1 listed)
- patients refusing the study
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 |
|---|---|---|
| trabeculotomy ( angle glaucoma surgery )a scleral flap is raised at the selected site with UBM and a cutdown in shlemm's canal is performed, a metal trabeculotome is used to cannulate and tear through a section of the inner wall of SC and trabeculum into the AC. Closure of the scleral flap and conjunctiva with 10/0 nylon. Viscoelastic is used to dilate the schlemm's canal, form the anterior chamber and decrease the risk of hyphema. | Procedure or surgery | pediatric glaucoma patients either primary or secondary |
Primary outcome
Intraocular pressure
Time frame: 6 months
success of glaucoma surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2022.
- Individual participant dataSharing planned: No. results
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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 trabeculotomy ( angle glaucoma surgery ) in people with Glaucoma Pediatric, run by Mansoura 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 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: status not confirmed, as of the sponsor's last update on 7 Sep 2022. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraocular pressure (time frame: 6 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 7 Sep 2022.