Primary Congenital GlaucomaNCT04116450
MicrocatheterTrabeculotomy in Primary Congenital Glaucoma
A study testing Glaucolight illuminated microcatheter. in people with Primary Congenital Glaucoma, run by Minia University at 1 site in Egypt.
Trial summary
PURPOSE: To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter. Setting: Ophthalmology department, Faculty of Medicine, Minia University, 61519, El-Minia, Egypt. Read more about this study
- Who is it for?
- Ages 2 to 48 months
- Conditions the study is for
- Primary Congenital Glaucoma
- What is being tested?
- Glaucolight illuminated microcatheter.
- Type of treatment
- 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 Jun 2017to 31 May 2019
- 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 2 to 48 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.
Who cannot join
- Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Microcatheter Assisted Circumferential Trabeculotomy in Congenital Glaucoma
PURPOSE: To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
Setting: Ophthalmology department, Faculty of Medicine, Minia University, 61519, El-Minia, Egypt.
Read more
DESIGN: Prospective, randomized, consecutive interventional study
METHODS:
This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential trabeculotomy done with an illuminated microcatheter through a period of 24 months. Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change.
Read the detailed description
Subjects and Methods This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential 360° trabeculotomy done with an illuminated microcatheter (DORC International, Zuidland, Netherlands) through a period of 24 months from June 2017 to May 2019. The child parents were informed by the procedure and signed a consent as well as the study was approved from Ethical Committees and was in accordance with the Declaration of Helsinki.
inclusion criteria: The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.
Exclusion criteria: Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.
Preoperative examinations: Routine ocular examination or under general anesthesia for younger children were done after history taking including, age, sex, laterality, family history and consanguinity, antiglaucoma drugs. The ocular examinations includes IOP with Goldman applanation or Perkins tonometer, slit lamp, corneal clarity, measurement of horizontal corneal diameter, axial length by ultrasonography and fundus examination and measurement of cup disc ratio. The demographic data were registered as in (Table 1).
Surgical procedure:
Under general anesthesia, routine ophthalmology srcupping and sterilization. Eye speculum was inserted then
- Conjunctival peritomy with fornix based flap was done.
- Superficial rectangular scleral flab 3.5 x 4.5 mm and deep scleral flab 2 x 3 mm with deroofing of Sclemm's canal anteriorly to the scleral spur were done.
- Cutting Sclemm's canal and exposure of its ostia and dilatation of the ostia by injection of Healon.
- Paracentesis to lower IOP and injection of Miochol for miosis and Healon to keep anterior chamber stable and deep.
- Introducing the illuminated catheter into one of the Sclemm's canal ostium and advanced through the whole Sclemm's canal 360° circumference.
- When the atraumatic tip of the catheter appeared from the other ostium, both ends were pulled in opposite direction to make 360° trabeculotomy.
- Both Scleral flaps were closed with interrupted 10/0 nylon suture and Conjunctival flap with contentious 10/0 nylon suture.
- Injection of subconjunctival steroid and antibiotic, then eye dressing.
Post-operative management :
The patients were prescribed topical tobradex( tobramycin- dexamethasone) eye drops QID and tapering through 4-6 weeks and topical cycloplegic eye drops TID for 3 days. Scheduled follow up visits were advised next postoperative day, one week, monthly for three months then each three months till one year. Each visit the child subjected to full ophthalmological examinations previously mentioned and antiglaucoma medications were prescribed when needed (IOP<21 mmHg) or appearing of signs of glaucoma progression starting by one drug beta blockers and adding dorzolamide or prostaglandin to reach the target IOP.
Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs, a qualified success when medications were used to reach this aim and failure if the target IOP would not reached in spite of full antiglaucoma medication and the child needs another antiglaucoma procedure. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change. The results of one week, 3 months, 6 months and one year were included in the statistical analysis.
statistical analysis: Data were collected, revised, verified, coded, then entered PC for statistical analysis done by using SPSS statistical package version 20. Descriptive statistics for quantitative data: mean (X) and standard deviation (SD). Kolmogorov- Smirnov for normality test was used to differentiate between parametric data and non-parametric data. Statistical analysis using Wilcoxon signed ranks test for comparison of two related parameters preoperative and postoperative. For all tests probability (P value) was considered non-significant if ≥ 0.05, significant if < 0.05, highly significant if < 0.01 and very highly significant if <0.001.
- Conditions
- Primary Congenital Glaucoma
- Being tested
- Glaucolight illuminated microcatheter.
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucolight illuminated microcatheter.Procedure or surgery
Also called circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
| Study group | Role | What they receive |
|---|---|---|
| primary congenital glaucoma | Other | Glaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma Receives: Procedure: Glaucolight illuminated microcatheter. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intra-ocular pressure
The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim.
Measured: one year
Secondary outcomes (2)
corneal diameer
The secondary target was studding the corneal diameter (CD)
Measured: 1 year
cup discratio
cup disc ratio (C/D) change.
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 posted4 Oct 2019
- Study start1 Jun 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 25 patient underwent Glaucolight illuminated microcatheter for primary congenital glaucoma
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shaaban Elwan, Minia University
- Investigators
- mahmoud M Genaidy, MD, Study director, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04116450
- Sponsor's protocol ID
- Minia U, Glaucoma unit
- Status last verified
- Oct 2019
- First submitted
- 1 Oct 2019
- Last updated
- 4 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: freely share
Publications
El Sayed Y, Gawdat G. Two-year results of microcatheter-assisted trabeculotomy in paediatric glaucoma: a randomized controlled study. Acta Ophthalmol. 2017 Dec;95(8):e713-e719. doi: 10.1111/aos.13414. Epub 2017 Mar 7.
PubMed 28266150Morales J, Al Shahwan S, Al Odhayb S, Al Jadaan I, Edward DP. Current surgical options for the management of pediatric glaucoma. J Ophthalmol. 2013;2013:763735. doi: 10.1155/2013/763735. Epub 2013 Apr 24.
PubMed 23738051
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microcatheter Assisted Circumferential Trabeculotomy in Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT04116450
- Acronym / sponsor ID
- Minia U, Glaucoma unit
- Conditions
- Primary Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 4 Oct 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.
PURPOSE: To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.
Setting: Ophthalmology department, Faculty of Medicine, Minia University, 61519, El-Minia, Egypt.
DESIGN: Prospective, randomized, consecutive interventional study
METHODS:
This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential trabeculotomy done with an illuminated microcatheter through a period of 24 months. Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change.
Detailed description
Subjects and Methods This was a prorospective study of 25 eyes of 25 patients with primary congenital or juvenile glaucoma those underwent circumferential 360° trabeculotomy done with an illuminated microcatheter (DORC International, Zuidland, Netherlands) through a period of 24 months from June 2017 to May 2019. The child parents were informed by the procedure and signed a consent as well as the study was approved from Ethical Committees and was in accordance with the Declaration of Helsinki.
inclusion criteria: The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.
Exclusion criteria: Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.
Preoperative examinations: Routine ocular examination or under general anesthesia for younger children were done after history taking including, age, sex, laterality, family history and consanguinity, antiglaucoma drugs. The ocular examinations includes IOP with Goldman applanation or Perkins tonometer, slit lamp, corneal clarity, measurement of horizontal corneal diameter, axial length by ultrasonography and fundus examination and measurement of cup disc ratio. The demographic data were registered as in (Table 1).
Surgical procedure:
Under general anesthesia, routine ophthalmology srcupping and sterilization. Eye speculum was inserted then
- Conjunctival peritomy with fornix based flap was done.
- Superficial rectangular scleral flab 3.5 x 4.5 mm and deep scleral flab 2 x 3 mm with deroofing of Sclemm's canal anteriorly to the scleral spur were done.
- Cutting Sclemm's canal and exposure of its ostia and dilatation of the ostia by injection of Healon.
- Paracentesis to lower IOP and injection of Miochol for miosis and Healon to keep anterior chamber stable and deep.
- Introducing the illuminated catheter into one of the Sclemm's canal ostium and advanced through the whole Sclemm's canal 360° circumference.
- When the atraumatic tip of the catheter appeared from the other ostium, both ends were pulled in opposite direction to make 360° trabeculotomy.
- Both Scleral flaps were closed with interrupted 10/0 nylon suture and Conjunctival flap with contentious 10/0 nylon suture.
- Injection of subconjunctival steroid and antibiotic, then eye dressing.
Post-operative management :
The patients were prescribed topical tobradex( tobramycin- dexamethasone) eye drops QID and tapering through 4-6 weeks and topical cycloplegic eye drops TID for 3 days. Scheduled follow up visits were advised next postoperative day, one week, monthly for three months then each three months till one year. Each visit the child subjected to full ophthalmological examinations previously mentioned and antiglaucoma medications were prescribed when needed (IOP<21 mmHg) or appearing of signs of glaucoma progression starting by one drug beta blockers and adding dorzolamide or prostaglandin to reach the target IOP.
Patients data of 12 months follow-up were recorded. The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs, a qualified success when medications were used to reach this aim and failure if the target IOP would not reached in spite of full antiglaucoma medication and the child needs another antiglaucoma procedure. The secondary target was studding the corneal diameter (CD) and cup disc ratio (C/D) change. The results of one week, 3 months, 6 months and one year were included in the statistical analysis.
statistical analysis: Data were collected, revised, verified, coded, then entered PC for statistical analysis done by using SPSS statistical package version 20. Descriptive statistics for quantitative data: mean (X) and standard deviation (SD). Kolmogorov- Smirnov for normality test was used to differentiate between parametric data and non-parametric data. Statistical analysis using Wilcoxon signed ranks test for comparison of two related parameters preoperative and postoperative. For all tests probability (P value) was considered non-significant if ≥ 0.05, significant if < 0.05, highly significant if < 0.01 and very highly significant if <0.001.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 25 patient underwent Glaucolight illuminated microcatheter for primary congenital glaucoma
| Arm | Type | Receives |
|---|---|---|
| primary congenital glaucoma | Other | Procedure: Glaucolight illuminated microcatheter.Glaucolight illuminated microcatheter trabeculotomy in primary congenital glaucoma |
Who may qualify
- Ages
- 2 to 48 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- The study included children aged below 6 years with PCG with or without antiglaucoma medications and not had previous antiglaucoma surgery with successful 360°trabeculotomy.
Key exclusion criteria (1 listed)
- Eyes that needs combined operation, previous antiglaucoma procedure and incomplete trabeculotomy ≤360°.
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 |
|---|---|---|
| Glaucolight illuminated microcatheter.Also: circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter.To study circumferential trabeculotomy for congenital glaucoma using Glaucolight illuminated microcatheter. | Procedure or surgery | primary congenital glaucoma |
Primary outcome
Intra-ocular pressure
Time frame: one year
The primary target was mean intraocular pressure (IOP) study in which unqualified (complete success) was defined as an IOP ≤21 mm Hg and at least a 30% reduction without the use of antiglaucoma drugs and a qualified success when medications were used to reach this aim.
2 secondary outcomes
corneal diameer
Time frame: 1 year
cup discratio
Time frame: 1 year
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 4 Oct 2019.
- Background: PubMed 28266150El Sayed Y, Gawdat G. Two-year results of microcatheter-assisted trabeculotomy in paediatric glaucoma: a randomized controlled study. Acta Ophthalmol. 2017 Dec;95(8):e713-e719. doi: 10.1111/aos.13414. Epub 2017 Mar 7.
- Background: PubMed 23738051Morales J, Al Shahwan S, Al Odhayb S, Al Jadaan I, Edward DP. Current surgical options for the management of pediatric glaucoma. J Ophthalmol. 2013;2013:763735. doi: 10.1155/2013/763735. Epub 2013 Apr 24.
- Individual participant dataSharing planned: No. freely share
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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.
mahmoud M Genaidy, MD study director
Minia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucolight illuminated microcatheter. in people with Primary Congenital Glaucoma, run by Minia 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: finished, as of the sponsor's last update on 4 Oct 2019. 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: one 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 NCT04116450, which also lists 2 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 4 Oct 2019.