Optical Coherence TomographyNCT07012252
Optical Coherence Tomography of the Irido-Corneal Angle Before and After Goniotomy and Trabeculotomy in Primary Congenital Glaucoma
A study testing Optical coherence tomography in people with Optical Coherence Tomography and Anterior Chamber Angle, run by Cairo University at 1 site in Egypt.
Trial summary
The research aimed to improve surgical techniques and long-term outcomes by utilizing this advanced imaging technology to illuminate the structural abnormalities of the anterior segment in eyes with primary congenital glaucoma. Read more about this study
- Who is it for?
- Ages 1 week to 72 weeks
- Conditions the study is for
- Optical Coherence Tomography, Anterior Chamber Angle, Goniotomy
- What is being tested?
- Optical coherence tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2018to 1 Nov 2020
- 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 week to 72 weeks
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Age from 1 to 72 weeks.
- Both sexes.
- Infants with primary congenital glaucoma.
Who cannot join
- Eyes in which the angle could not be visualized by the handheld anterior segment optical coherence tomography (HH AS-OCT).
- Eyes with previous intraocular surgery.
Trial locations and contacts
1 site in 1 country.
About this study
The research aimed to improve surgical techniques and long-term outcomes by utilizing this advanced imaging technology to illuminate the structural abnormalities of the anterior segment in eyes with primary congenital glaucoma.
Read the detailed description
Primary congenital glaucoma (PCG) is a rare disease, but it is responsible for 2.5%-15% of all documented cases of pediatric blindness.
The main target of the treatment of pediatric glaucoma is to control the IOP surgically. However, medical treatment could be instituted as a temporary and/or adjunctive option to maximize Intraocular pressure (IOP) control. Initial goniotomy or trabeculotomy have been detected to have high success rates. Trabeculotomy has a comparable long-term success rate in most patients of PCG. The success rate of trabeculotomy is lower in advanced or late-presenting patients.
- Conditions
- Optical Coherence Tomography, Anterior Chamber Angle, Goniotomy, Trabeculotomy, Primary Congenital Glaucoma
- Being tested
- Optical coherence tomography
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical coherence tomographyProcedure or surgery
Infants underwent optical coherence tomography.
| Study group | Role | What they receive |
|---|---|---|
| Primary congenital glaucoma group | Experimental | Infants with primary congenital glaucoma. Receives: Procedure: Optical coherence tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Central corneal thickness
Central corneal thickness was measured using handheld anterior segment optical coherence tomography (HH AS-OCT).
Measured: 6 months post-procedure
Secondary outcomes (2)
Trabecular-iris angle
Trabecular-iris angle was measured using handheld anterior segment optical coherence tomography (HH AS-OCT).
Measured: 6 months post-procedure
Iris thickness
Iris thickness was measured using handheld anterior segment optical coherence tomography (HH AS-OCT).
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2025
- Study start1 Oct 2018
- Primary completion1 Nov 2020
- Study completion1 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optical Coherence TomographyStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maha Mosaad Mohammed Zmetar, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07012252
- Sponsor's protocol ID
- D-36-2019
- Status last verified
- May 2025
- First submitted
- 31 May 2025
- Last updated
- 10 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography of the Irido-Corneal Angle Before and After Goniotomy and Trabeculotomy in Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT07012252
- Acronym / sponsor ID
- D-36-2019
- Conditions
- Optical Coherence Tomography, Anterior Chamber Angle, Goniotomy, Trabeculotomy, Primary Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 1 Nov 2020 (actual)
- First posted
- 10 Jun 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.
The research aimed to improve surgical techniques and long-term outcomes by utilizing this advanced imaging technology to illuminate the structural abnormalities of the anterior segment in eyes with primary congenital glaucoma.
Detailed description
Primary congenital glaucoma (PCG) is a rare disease, but it is responsible for 2.5%-15% of all documented cases of pediatric blindness.
The main target of the treatment of pediatric glaucoma is to control the IOP surgically. However, medical treatment could be instituted as a temporary and/or adjunctive option to maximize Intraocular pressure (IOP) control. Initial goniotomy or trabeculotomy have been detected to have high success rates. Trabeculotomy has a comparable long-term success rate in most patients of PCG. The success rate of trabeculotomy is lower in advanced or late-presenting patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Primary congenital glaucoma group | Experimental | Procedure: Optical coherence tomographyInfants with primary congenital glaucoma. |
Who may qualify
- Ages
- 1 week to 72 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Age from 1 to 72 weeks.
- Both sexes.
- Infants with primary congenital glaucoma.
Key exclusion criteria (2 listed)
- Eyes in which the angle could not be visualized by the handheld anterior segment optical coherence tomography (HH AS-OCT).
- Eyes with previous intraocular surgery.
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 |
|---|---|---|
| Optical coherence tomographyInfants underwent optical coherence tomography. | Procedure or surgery | Primary congenital glaucoma group |
Primary outcome
Central corneal thickness
Time frame: 6 months post-procedure
Central corneal thickness was measured using handheld anterior segment optical coherence tomography (HH AS-OCT).
2 secondary outcomes
Trabecular-iris angle
Time frame: 6 months post-procedure
Iris thickness
Time frame: 6 months post-procedure
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 10 Jun 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
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 Optical coherence tomography in people with Optical Coherence Tomography and Anterior Chamber Angle, 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 3 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 10 Jun 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?
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?
Central corneal thickness (time frame: 6 months post-procedure). 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 10 Jun 2025.