Primary Congenital GlaucomaNCT04079725
Iris Tissue in Primary Congenital Glaucoma
A study testing Combined trabeculotomy-trabeculectomy with mitomycin c in people with Primary Congenital Glaucoma, run by Assiut University.
Trial summary
To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis Read more about this study
- Who is it for?
- Ages 7 days to 1 year
- 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
- 15 participants
- Where
- No sites listed yet
- Study dates
- Dec 2020to Mar 2022
- 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 7 days to 1 year
- 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: Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma
To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis
Read the detailed description
Primary congenital glaucoma etiology still remains obscure . originally barkan , and later Worst , proposed that a membrane covered the anterior chamber angle and blocked aqueous outflow , but the presence of that membrane has not been established histopathologically to date . Now most authors believe that the site of obstruction is the trabecular meshwork rather than an overlying membrane . Maldevelopment of the anterior segment is present in all forms of congenital glaucoma . this maldevelopment may involve the trabecular meshwork alone or the trabecular meshwork in combination with the iris or cornea or both. In approcimately 50% of patients , isolated trabeculodysgensis is the only developmental ocular anomaly found .This is the classic defect found in primary congenital glaucoma .These eyes have no developmental anomalies of iris or cornea present except abnormal insertion of the iris into the angle
- 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
Also called Histopathological examination of iris tissue
Combined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases then histopathological examination of iris tissue to detect the nature of the disease
| Study group | Role | What they receive |
|---|---|---|
| Experimental : 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.
Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis
Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startDec 2020 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionMar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)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 Assiut 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Abdelkarem Hasan, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04079725
- Sponsor's protocol ID
- primary congenital glaucoma
- Status last verified
- Oct 2020
- First submitted
- 30 Aug 2019
- Last updated
- 22 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mandal AK, Naduvilath TJ, Jayagandan A. Surgical results of combined trabeculotomy-trabeculectomy for developmental glaucoma. Ophthalmology. 1998 Jun;105(6):974-82. doi: 10.1016/S0161-6420(98)96022-5.
PubMed 9627644Suri F, Yazdani S, Narooie-Nejhad M, Zargar SJ, Paylakhi SH, Zeinali S, Pakravan M, Elahi E. Variable expressivity and high penetrance of CYP1B1 mutations associated with primary congenital glaucoma. Ophthalmology. 2009 Nov;116(11):2101-9. doi: 10.1016/j.ophtha.2009.04.045. Epub 2009 Sep 10.
PubMed 19744731Biglan AW. Glaucoma in children: are we making progress? J AAPOS. 2006 Feb;10(1):7-21. doi: 10.1016/j.jaapos.2005.10.001.
PubMed 16527674Black AC, Jones S, Yanovitch TL, Enyedi LB, Stinnett SS, Freedman SF. Latanoprost in pediatric glaucoma--pediatric exposure over a decade. J AAPOS. 2009 Dec;13(6):558-62. doi: 10.1016/j.jaapos.2009.10.003.
PubMed 20006816Kargi SH, Koc F, Biglan AW, Davis JS. Visual acuity in children with glaucoma. Ophthalmology. 2006 Feb;113(2):229-38. doi: 10.1016/j.ophtha.2005.10.029. Epub 2006 Jan 10.
PubMed 16406536Mandal AK, Gothwal VK, Bagga H, Nutheti R, Mansoori T. Outcome of surgery on infants younger than 1 month with congenital glaucoma. Ophthalmology. 2003 Oct;110(10):1909-15. doi: 10.1016/S0161-6420(03)00671-7.
PubMed 14522762Ocular Pathology Atlas. American Academy of Ophthalmology Web site. https://www.aao.org/resident-course/pathology-atlas. Published 2016. Accessed January 4, 2017
American Academy of Ophthalmology. Congenital glaucoma, cloudy corneas. https://www.aao.org/image/congenital-glaucoma-cloudy-corneas-2 Accessed July 01, 2019
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histopathological Examination of Iris Tissue in Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT04079725
- Acronym / sponsor ID
- primary congenital glaucoma
- Conditions
- Primary Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2020 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Mar 2022 (estimated)
- First posted
- 6 Sep 2019 (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.
To present the histopathological features of the iris tissue in primary congenital glaucoma which may play a role in pathogenesis
Detailed description
Primary congenital glaucoma etiology still remains obscure . originally barkan , and later Worst , proposed that a membrane covered the anterior chamber angle and blocked aqueous outflow , but the presence of that membrane has not been established histopathologically to date . Now most authors believe that the site of obstruction is the trabecular meshwork rather than an overlying membrane . Maldevelopment of the anterior segment is present in all forms of congenital glaucoma . this maldevelopment may involve the trabecular meshwork alone or the trabecular meshwork in combination with the iris or cornea or both. In approcimately 50% of patients , isolated trabeculodysgensis is the only developmental ocular anomaly found .This is the classic defect found in primary congenital glaucoma .These eyes have no developmental anomalies of iris or cornea present except abnormal insertion of the iris into the angle
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Experimental : Infants with primary congenital glaucoma | Experimental | Procedure: Combined trabeculotomy-trabeculectomy with mitomycin c |
Who may qualify
- Ages
- 7 days to 1 year
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Typical symptoms of epiphora , photophobia and blepharospasm
- corneal diameter > 13 mm
- Increased ocular tension > 25 mmHg UGA using schiotz tonometer
Key exclusion criteria (3 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 cAlso: Histopathological examination of iris tissueCombined trabeculotomy-trabeculectomy with mitomycin C Will be done in all cases then histopathological examination of iris tissue to detect the nature of the disease | Procedure or surgery | Experimental : Infants with primary congenital glaucoma |
Primary outcome
Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis
Time frame: 2 years
Histopathological features of iris tissue in infants with primary congenital glaucoma who underwent Combined trabeculotomy-trabeculectomy with mitomycin C
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2020.
- Background: PubMed 9627644Mandal AK, Naduvilath TJ, Jayagandan A. Surgical results of combined trabeculotomy-trabeculectomy for developmental glaucoma. Ophthalmology. 1998 Jun;105(6):974-82. doi: 10.1016/S0161-6420(98)96022-5.
- Background: PubMed 19744731Suri F, Yazdani S, Narooie-Nejhad M, Zargar SJ, Paylakhi SH, Zeinali S, Pakravan M, Elahi E. Variable expressivity and high penetrance of CYP1B1 mutations associated with primary congenital glaucoma. Ophthalmology. 2009 Nov;116(11):2101-9. doi: 10.1016/j.ophtha.2009.04.045. Epub 2009 Sep 10.
- Background: PubMed 16527674Biglan AW. Glaucoma in children: are we making progress? J AAPOS. 2006 Feb;10(1):7-21. doi: 10.1016/j.jaapos.2005.10.001.
- Background: PubMed 20006816Black AC, Jones S, Yanovitch TL, Enyedi LB, Stinnett SS, Freedman SF. Latanoprost in pediatric glaucoma--pediatric exposure over a decade. J AAPOS. 2009 Dec;13(6):558-62. doi: 10.1016/j.jaapos.2009.10.003.
- Background: PubMed 16406536Kargi SH, Koc F, Biglan AW, Davis JS. Visual acuity in children with glaucoma. Ophthalmology. 2006 Feb;113(2):229-38. doi: 10.1016/j.ophtha.2005.10.029. Epub 2006 Jan 10.
- Background: PubMed 14522762Mandal AK, Gothwal VK, Bagga H, Nutheti R, Mansoori T. Outcome of surgery on infants younger than 1 month with congenital glaucoma. Ophthalmology. 2003 Oct;110(10):1909-15. doi: 10.1016/S0161-6420(03)00671-7.
- BackgroundOcular Pathology Atlas. American Academy of Ophthalmology Web site. https://www.aao.org/resident-course/pathology-atlas. Published 2016. Accessed January 4, 2017
- BackgroundAmerican Academy of Ophthalmology. Congenital glaucoma, cloudy corneas. https://www.aao.org/image/congenital-glaucoma-cloudy-corneas-2 Accessed July 01, 2019
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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 Assiut University.
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 3 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 22 Oct 2020. 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. (+201000525341, oabdelkarem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Present histopathological features of iris tissue in infants with primary congenital glaucoma which may play a role in pathogenesis (time frame: 2 years). 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 NCT04079725, which also lists 8 linked publications.
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 22 Oct 2020.