Primary Congenital GlaucomaNCT07830017
Combined Nasal Goniotomy-Temporal Trabeculotomy Versus Temporal Trabeculotomy for Management of Primary Congenital Glaucoma
A study testing combined Nasal goniotomy-Temporal trabeculotomy and Temporal trabeculotomy in people with Primary Congenital Glaucoma, run by Zagazig University at 1 site in Egypt.
Trial summary
Combined nasal goniotomy and temporal trabeculotomy provides effective IOP control in PCG while preserving the superior conjunctiva for future filtering procedures. By expanding the treated angle area and sparing the superior conjunctiva, this operation provides a synergistic approach that may improve long-term… Read more about this study
- Who is it for?
- Ages 1 day to 2 years
- Conditions the study is for
- Primary Congenital Glaucoma
- What is being tested?
- combined Nasal goniotomy-Temporal trabeculotomy and Temporal trabeculotomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2024to 1 Feb 2026
- 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 1 day to 2 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Child with primary congenital glaucoma
Who cannot join
- associated ocular diseases other than glaucom
- posterior segment congenital anomalies
Trial locations and contacts
1 site in 1 country.
About this study
Combined nasal goniotomy and temporal trabeculotomy provides effective IOP control in PCG while preserving the superior conjunctiva for future filtering procedures. By expanding the treated angle area and sparing the superior conjunctiva, this operation provides a synergistic approach that may improve long-term management strategies for pediatric glaucoma
Read the detailed description
Primary congenital glaucoma (PCG) is the main category of primary childhood glaucoma. Classically, PCG presents with one or more of the following clinical manifestations: increased corneal diameters, corneal opacification, photophobia, and excessive tearing. The increased intraocular pressure (IOP) in PCG is mainly due to an immature anterior chamber (AC) angle with inadequate aqueous filtration through the trabecular meshwork (TM). 1 Reduction of IOP in PCG relies mainly on surgical treatment. Wide variations in surgical procedures exist for the treatment of PCG, with different principles and steps. The idea behind angle-based surgeries is to remove the main barrier to aqueous filtration and create a direct pathway for aqueous to reach the Schlemm's Canal (SC). Other surgeries, such as trabeculectomy or implantation of Glaucoma drainage devices (GDD), divert the aqueous drainage toward the sub-tenon space away from the occluded TM.2,3 and 4 PCG treatment may entail the need for more than one surgery to correct the IOP. Combining two or more surgical procedures in the same setting may produce a synergistic effect in reducing the IOP while reducing the psychological and surgical burden on PCG patients. In the combined Nasal Goniotomy-Temporal Trabeculotomy (NGTT) procedure, preservation of the superior conjunctiva is an advantage that increases the success rates of further surgeries if needed. 5 In this study, the authors studied a real-world comparison between NGTT and single-site trabeculotomy for the management of PCG patients.
- Conditions
- Primary Congenital Glaucoma
- Being tested
- combined Nasal goniotomy-Temporal trabeculotomy, Temporal trabeculotomy
- Keywords
- Glaucoma, Congenital, Trabeculotomy, Goniotomy
- Medical subject headings
- Hydrophthalmos, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
combined Nasal goniotomy-Temporal trabeculotomyProcedure or surgery
Temporal trabeculotomy
Temporal trabeculotomyProcedure or surgery
Temporal trabeculotomy
| Study group | Role | What they receive |
|---|---|---|
| combined Nasal goniotomy-Temporal trabeculotomy | Active comparator | combined nasal goniotomy-Temporal trabeculotomy Receives: Procedure: combined Nasal goniotomy-Temporal trabeculotomy |
| Temporal trabeculotomy | Active comparator | Temporal trabeculotomy Receives: Procedure: Temporal trabeculotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
intra ocular pressure
post operative IOP compared to preoperative IOP
Measured: 1 YEAR
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2026
- Study start1 Feb 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Congenital 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Mohammed Alsaeed Al Naimy Habeeb, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07830017
- Sponsor's protocol ID
- ZU-IRB#11426/11-F1EB-2024
- Status last verified
- Sep 2026
- First submitted
- 23 May 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anderson DR. Trabeculotomy compared to goniotomy for glaucoma in children. Ophthalmology. 1983 Jul;90(7):805-6. doi: 10.1016/s0161-6420(83)34484-5.
PubMed 6622020
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Nasal Goniotomy-Temporal Trabeculotomy Versus Temporal Trabeculotomy for Management of Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT07830017
- Acronym / sponsor ID
- ZU-IRB#11426/11-F1EB-2024
- Conditions
- Primary Congenital Glaucoma
- Keywords
- Glaucoma, Congenital, Trabeculotomy, Goniotomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 21 Sep 2026 (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.
Combined nasal goniotomy and temporal trabeculotomy provides effective IOP control in PCG while preserving the superior conjunctiva for future filtering procedures. By expanding the treated angle area and sparing the superior conjunctiva, this operation provides a synergistic approach that may improve long-term management strategies for pediatric glaucoma
Detailed description
Primary congenital glaucoma (PCG) is the main category of primary childhood glaucoma. Classically, PCG presents with one or more of the following clinical manifestations: increased corneal diameters, corneal opacification, photophobia, and excessive tearing. The increased intraocular pressure (IOP) in PCG is mainly due to an immature anterior chamber (AC) angle with inadequate aqueous filtration through the trabecular meshwork (TM). 1 Reduction of IOP in PCG relies mainly on surgical treatment. Wide variations in surgical procedures exist for the treatment of PCG, with different principles and steps. The idea behind angle-based surgeries is to remove the main barrier to aqueous filtration and create a direct pathway for aqueous to reach the Schlemm's Canal (SC). Other surgeries, such as trabeculectomy or implantation of Glaucoma drainage devices (GDD), divert the aqueous drainage toward the sub-tenon space away from the occluded TM.2,3 and 4 PCG treatment may entail the need for more than one surgery to correct the IOP. Combining two or more surgical procedures in the same setting may produce a synergistic effect in reducing the IOP while reducing the psychological and surgical burden on PCG patients. In the combined Nasal Goniotomy-Temporal Trabeculotomy (NGTT) procedure, preservation of the superior conjunctiva is an advantage that increases the success rates of further surgeries if needed. 5 In this study, the authors studied a real-world comparison between NGTT and single-site trabeculotomy for the management of PCG patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| combined Nasal goniotomy-Temporal trabeculotomy | Active comparator | Procedure: combined Nasal goniotomy-Temporal trabeculotomycombined nasal goniotomy-Temporal trabeculotomy |
| Temporal trabeculotomy | Active comparator | Procedure: Temporal trabeculotomyTemporal trabeculotomy |
Who may qualify
- Ages
- 1 day to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Child with primary congenital glaucoma
Key exclusion criteria (2 listed)
- associated ocular diseases other than glaucom
- posterior segment congenital anomalies
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 |
|---|---|---|
| combined Nasal goniotomy-Temporal trabeculotomyTemporal trabeculotomy | Procedure or surgery | combined Nasal goniotomy-Temporal trabeculotomy |
| Temporal trabeculotomyTemporal trabeculotomy | Procedure or surgery | Temporal trabeculotomy |
Primary outcome
intra ocular pressure
Time frame: 1 YEAR
post operative IOP compared to preoperative IOP
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 21 Sep 2026.
- Background: PubMed 6622020Anderson DR. Trabeculotomy compared to goniotomy for glaucoma in children. Ophthalmology. 1983 Jul;90(7):805-6. doi: 10.1016/s0161-6420(83)34484-5.
- Individual participant dataSharing planned: No
Related trials for Primary Congenital Glaucoma
RecruitingPhase 1/2
GVB-2001 Gene Therapy Via Intracameral Injection for the Treatment of Primary Open Angle Glaucoma
Primary Open-Angle Glaucoma (POAG)
Not yet recruitingObservational study
Goniotomy in Primary Congenital Glaucoma
Primary Congenital Glaucoma, Goniotomy
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 combined Nasal goniotomy-Temporal trabeculotomy and Temporal trabeculotomy in people with Primary Congenital Glaucoma, run by Zagazig 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 2 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 21 Sep 2026. 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?
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?
intra ocular pressure (time frame: 1 YEAR). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07830017, which also lists 1 linked publication.
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 21 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.