Primary Congenital GlaucomaNCT05205122
Evaluation of Primary Congenital Glaucoma at Asyut University Hospital
A study testing Combined trabeculotomy-trabeculectomy with mitomycin C in people with Primary Congenital Glaucoma, run by Omar Abdelkarem Hasan.
Trial summary
Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital Read more about this study
- Who is it for?
- Ages 1 day to 3 years
- Conditions the study is for
- Primary Congenital Glaucoma
- What is being tested?
- Combined trabeculotomy-trabeculectomy with mitomycin C
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2022to 1 Jan 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 1 day to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Who cannot join
- Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other congenital anomalies
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of Primary Congenital Glaucoma Management at Asyut University Hospital
Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital
- Conditions
- Primary Congenital Glaucoma
- Being tested
- Combined trabeculotomy-trabeculectomy with mitomycin C
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined trabeculotomy-trabeculectomy with mitomycin CProcedure or surgery
Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases
| Study group | Role | What they receive |
|---|---|---|
| Infants with primary congenital glaucoma | Experimental | Not described Receives: Procedure: Combined trabeculotomy-trabeculectomy with mitomycin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP follow up
postoperative measurment of Intra ocular pressure by shoitz tonometer
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 posted24 Jan 2022
- Study start1 Feb 2022 (estimated)
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Congenital GlaucomaStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Omar Abdelkarem Hasan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Omar Abdelkarem Hasan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05205122
- Sponsor's protocol ID
- Congenital glaucoma
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 24 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Primary Congenital Glaucoma Management at Asyut University Hospital
- ClinicalTrials.gov ID
- NCT05205122
- Acronym / sponsor ID
- Congenital glaucoma
- Conditions
- Primary Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Omar Abdelkarem HasanUniversity, hospital or other
- Study start
- 1 Feb 2022 (estimated)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 24 Jan 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.
Evaluation of the management of primary congenital glaucoma regarding the results of surgical intervention at Asyut University Hospital
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infants with primary congenital glaucoma | Experimental | Procedure: Combined trabeculotomy-trabeculectomy with mitomycin C |
Who may qualify
- Ages
- 1 day to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Typical symptoms of epiphora , photophobia and blepharospasm Corneal diameter > 13 mm Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Key exclusion criteria (1 listed)
- Infants with history of previous surgery Secondary glaucoma Glaucoma associated with other 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 trabeculotomy-trabeculectomy with mitomycin CCombined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases | Procedure or surgery | Infants with primary congenital glaucoma |
Primary outcome
IOP follow up
Time frame: 1 year
postoperative measurment of Intra ocular pressure by shoitz tonometer
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2022.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Combined trabeculotomy-trabeculectomy with mitomycin C in people with Primary Congenital Glaucoma, run by Omar Abdelkarem Hasan.
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 24 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact Omar Abdelkarem Hasan, M.B.B.Ch. (00201000525341, oabdelkarem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP follow up (time frame: 1 year). 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 24 Jan 2022.