Glaucoma, Congenital, Surgical TreatmentInverte T trabNCT06837610
Inverted T Trabeculectomy Primary Congenital Glaucoma
A study testing Inverted T trabeculectomy in people with Glaucoma, Congenital, Surgical Treatment, run by Benha University at 1 site in Egypt.
Trial summary
This study aims to evaluate the safety and efficacy of novel Inverted T trabeculectomy in Primary Congenital Glaucoma (PCG). It enrolled 50 eyes of 25 children with PCG. The mean age at the time of surgery was 12±11 months, and the mean presenting IOP was 40±4 mmHg. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Glaucoma, Congenital, Surgical Treatment
- What is being tested?
- Inverted T trabeculectomy
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 1 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months
Who cannot join
- Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Inverted T Trabeculectomy for Primary Congenital Glaucoma, A Novel Technique
This study aims to evaluate the safety and efficacy of novel Inverted T trabeculectomy in Primary Congenital Glaucoma (PCG). It enrolled 50 eyes of 25 children with PCG. The mean age at the time of surgery was 12±11 months, and the mean presenting IOP was 40±4 mmHg. Patients with previous intra-ocular or conjunctival surgery, those who had significant ocular trauma, and patients with congenital glaucoma associated with ocular anomalies diseases were excluded from the study. All patients had Inverted T trabeculectomy under general anesthesia. The IOP in the operated eyes was followed up for 36 months.
Read the detailed description
This study included patients from the glaucoma clinic at Benha University Hospital between April 2015 and October 2017. All were diagnosed with PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months. Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study.
The procedure principles and potential complications were discussed with the children's parents or legal guardians, and they gave written informed consent before surgery. This study was approved by the Benha Faculty of Medicine's ethical committee (Approval number RC 9-1-2025) and conducted according to Helsinki's declaration.
All patients underwent complete ophthalmic examination under general anaesthesia before surgery. IOP was measured 5 minutes after injecting intravenous Ketamine 1mg/kg for induction of anaesthesia. We used a Perkins tonometer (Haag-Streit, UK) to measure the IOP before applying the eyelid speculum. Corneal clarity was assessed under a surgical microscope, the corneal diameter was recorded using a surgical caliber, and fundus examination was done by indirect ophthalmoscope. A surgical Swan Jacob gonioprism assessed the anterior chamber angle when the cornea was clear enough to achieve a good view.
All surgeries were performed under general anaesthesia by the same surgeon (AEH).
- Conditions
- Glaucoma, Congenital, Surgical Treatment
- Being tested
- Inverted T trabeculectomy
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inverted T trabeculectomyProcedure or surgery
- Fornix-based conjunctival incision along with the opening of Tenon's capsule and dissection along the area of the potential bleb.
- A 4 x 4 mm limbal-based scleral flap was fashioned using a crescent knife. Dissection was carried out up to the clear cornea.
- A longitudinal tunnel was made through the scleral bed, starting from the limbus and extending 1 mm beyond the end of the scleral flap. Afterwards, the horizontal limb of the Inverted T was created. (Figure 2)
- A paracentesis was made using an MVR blade.
- The anterior chamber was entered using an MVR blade. Kelly's punch was used to excise 1.5 x 1.5 mm of scleral bed at the limbus at the base of the vertical limb of the figure (T), and then a peripheral iridectomy was performed using Vannas scissors.
- The scleral flap was then closed using two fixed 10/0 Nylon sutures, one at each corner.
| Study group | Role | What they receive |
|---|---|---|
| Primary congenital glaucoma surgey | Other | Compare the Novel inverted T technique to the classic trabeculectomy in treatment of primary congenital glaucoma Receives: Procedure: Inverted T trabeculectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post op IOP
IOP lower than 21 mmHg or > 20% reduction from the baseline IOP in at least two consecutive follow-up visits without IOP-lowering medications and without vision-threatening complications
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2025
- Study start1 Jan 2023
- Primary completion1 Jul 2024
- Study completion1 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Congenital, Surgical TreatmentStudies 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
- Retrospective, non-controlled case series
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Abdelzaher Awwad, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06837610
- Sponsor's protocol ID
- Inverted T trab PCG
- Acronym
- Inverte T trab
- Status last verified
- Feb 2025
- First submitted
- 15 Feb 2025
- Last updated
- 20 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The data supporting this study's findings are available from the corresponding author, upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inverted T Trabeculectomy for Primary Congenital Glaucoma, A Novel Technique
- ClinicalTrials.gov ID
- NCT06837610
- Acronym / sponsor ID
- Inverte T trab / Inverted T trab PCG
- Conditions
- Glaucoma, Congenital, Surgical Treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Mar 2025 (estimated)
- First posted
- 20 Feb 2025 (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 aims to evaluate the safety and efficacy of novel Inverted T trabeculectomy in Primary Congenital Glaucoma (PCG). It enrolled 50 eyes of 25 children with PCG. The mean age at the time of surgery was 12±11 months, and the mean presenting IOP was 40±4 mmHg. Patients with previous intra-ocular or conjunctival surgery, those who had significant ocular trauma, and patients with congenital glaucoma associated with ocular anomalies diseases were excluded from the study. All patients had Inverted T trabeculectomy under general anesthesia. The IOP in the operated eyes was followed up for 36 months.
Detailed description
This study included patients from the glaucoma clinic at Benha University Hospital between April 2015 and October 2017. All were diagnosed with PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months. Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from the study.
The procedure principles and potential complications were discussed with the children's parents or legal guardians, and they gave written informed consent before surgery. This study was approved by the Benha Faculty of Medicine's ethical committee (Approval number RC 9-1-2025) and conducted according to Helsinki's declaration.
All patients underwent complete ophthalmic examination under general anaesthesia before surgery. IOP was measured 5 minutes after injecting intravenous Ketamine 1mg/kg for induction of anaesthesia. We used a Perkins tonometer (Haag-Streit, UK) to measure the IOP before applying the eyelid speculum. Corneal clarity was assessed under a surgical microscope, the corneal diameter was recorded using a surgical caliber, and fundus examination was done by indirect ophthalmoscope. A surgical Swan Jacob gonioprism assessed the anterior chamber angle when the cornea was clear enough to achieve a good view.
All surgeries were performed under general anaesthesia by the same surgeon (AEH).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Retrospective, non-controlled case series
| Arm | Type | Receives |
|---|---|---|
| Primary congenital glaucoma surgey | Other | Procedure: Inverted T trabeculectomyCompare the Novel inverted T technique to the classic trabeculectomy in treatment of primary congenital glaucoma |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- PCG based on an intraocular pressure (IOP) measurement of 21 mmHg or more at birth or shortly after, up to the age of 12 months
Key exclusion criteria (1 listed)
- Patients with previous intraocular or conjunctival surgery, those with significant ocular trauma, and those with congenital glaucoma associated with other ocular anomalies that would affect IOP were excluded from 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 |
|---|---|---|
| Inverted T trabeculectomy* Fornix-based conjunctival incision along with the opening of Tenon's capsule and dissection along the area of the potential bleb. * A 4 x 4 mm limbal-based scleral flap was fashioned using a crescent knife. Dissection was carried out up to the clear cornea. * A longitudinal tunnel was made through the scleral bed, starting from the limbus and extending 1 mm beyond the end of the scleral flap. Afterwards, the horizontal limb of the Inverted T was created. (Figure 2) * A paracentesis was made using an MVR blade. * The anterior chamber was entered using an MVR blade. Kelly's punch was used to excise 1.5 x 1.5 mm of scleral bed at the limbus at the base of the vertical limb of the figure (T), and then a peripheral iridectomy was performed using Vannas scissors. * The scleral flap was then closed using two fixed 10/0 Nylon sutures, one at each corner. | Procedure or surgery | Primary congenital glaucoma surgey |
Primary outcome
Post op IOP
Time frame: 18 months
IOP lower than 21 mmHg or > 20% reduction from the baseline IOP in at least two consecutive follow-up visits without IOP-lowering medications and without vision-threatening complications
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2025.
- Individual participant dataSharing planned: Undecided. The data supporting this study's findings are available from the corresponding author, upon reasonable request.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inverted T trabeculectomy in people with Glaucoma, Congenital, Surgical Treatment, run by Benha 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: under way, not looking for participants, as of the sponsor's last update on 20 Feb 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Post op IOP (time frame: 18 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 20 Feb 2025.