GlaucomaNCT05115708
Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma
A study testing ab externo viscotrabeculotomy and The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy in people with Glaucoma and Congenital Glaucoma, run by Mansoura University at 1 site in Egypt.
Trial summary
This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG. Read more about this study
- Who is it for?
- Ages 1 month to 10 years
- Conditions the study is for
- Glaucoma, Congenital Glaucoma
- What is being tested?
- ab externo viscotrabeculotomy and The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2021to Nov 2024
- 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 month to 10 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- primary congenital glaucoma
Who cannot join
- secondary congenital glaucoma
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura university ophthalmic center
Al Mansurah, 35516
Amr Abdelkader, MD, FRCS, 01004314242 ext. 020, dramrabdelkader@gmail.com
About this study
This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.
Read the detailed description
Introduction:
Ab externo viscotrabeculotomy is known as an effective surgical procedure used for managing primary congenital glaucoma (PCG) in which the Schlemm's canal (SC) is identified and a metal probe is inserted into the canal and rotated into the anterior chamber (AC) to perforate the SC inner wall.
Recently, Kahook dual blade (KDB) have been developed as one of the micro-invasive glaucoma surgical tools which removes a strip of the trabecular meshwork(TM) at the angle with superiority to simple goniotomy in treating the angle pathology in PCG.
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy is a simple procedure usually performed at the time of cataract surgery. It doesn't require sutures, and it carries no risk of bleb leaks or infections. It has a a quicker postoperative visual recovery than most other glaucoma treatments. The KDB device is specifically designed to produce targeted and fine tuned parallel incisions in the trabecular meshwork tissue for a quick and effective glaucoma treatment. The KDB's unique design enables precise excision of diseased trabecular meshwork (TM) to access multiple collector channels.
The KDB's unique design enables the operator to perform excisional goniotomy both during cataract surgery and as a stand alone procedure. The Kahook Dual Blade is a precise, intuitive surgical instrument utilized to perform excisional goniotomy.
Purpose:
This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.
Methods:
Sixty eyes of with PCG underwent ab-interno trabeculotomy using a KDB or ab externo viscotrabeculotomy. The study will be conducted at Mansoura university ophthalmic Center. Follow-up visits were scheduled at these post-operative dates: first day, first week, first month, 3rd month and then every 3 months for 2 years. Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.
Preoperative data including age, sex, laterality, type of glaucoma, ocular history, number of glaucoma medications, IOP, cup to disc ratio, and central corneal thickness (CCT) were record. Postoperative data included follow-up durations.
Statistical analysis:
All statistical analysis will be accomplished using IBM SPSS version 20. Assessment of the data normality will be done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used to compare the preoperative and postoperative variables in each group. The comparison between the two groups will be done using Mann-Whitney test for numerical variables and Chi-square test for categorical variables. Kaplan-Meier survival curve will be plotted to estimate the mean survival time and probabilities of failure at different follow-up stages in the both groups. For all tests, P value of less than 0.05 will be considered significant.
- Conditions
- Glaucoma, Congenital Glaucoma
- Being tested
- ab externo viscotrabeculotomy, The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
- Medical subject headings
- Glaucoma, Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ab externo viscotrabeculotomyProcedure or surgery
In brief, a fornix-based conjunctival incision is followed by fashioning and dissection of a triangular scleral flap. Radial incisions at the limbus followed to identify Schlemm's canal. viscotrabeculotomy, is performed by injection of high-viscosity sodium hyaluronate (Healon GV, Pfizer, NY) into Schlemm's canal prior to completion of the procedure with the metal trabeculotome. while a Nylon 10/0 suture in inserted into schlemm's canal in visco-circumferential-suture trabeculotomy group
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomyProcedure or surgery
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
| Study group | Role | What they receive |
|---|---|---|
| Kahook dual blade ab-interno Trabeculotomy | Active comparator | The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy Receives: Procedure: The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy |
| ab externo viscotrabeculotomy | Active comparator | In brief, a fornix-based conjunctival incision is followed by fashioning and dissection of a triangular scleral flap. Radial incisions at the limbus followed to identify Schlemm's canal. viscotrabeculotomy, is performed by injection of high-viscosity sodium hyaluronate (Healon GV, Pfizer, NY) into Schlemm's canal prior to completion of the procedure with the metal trabeculotome. while a Nylon 10/0 suture in inserted into schlemm's canal in visco-circumferential-suture trabeculotomy group. Receives: Procedure: ab externo viscotrabeculotomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
IOP
Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.
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 posted10 Nov 2021
- Study startNov 2021 (estimated)
- Primary completionNov 2023 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- Kahook dual blade ab-interno Trabeculotomy versus ab externo viscotrabeculotomy in treatment of primary congenital glaucoma.
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohammed Elsayed Abdelkader, Mansoura University
- Investigators
- Ahmed S Elwehidy, DM, Study chair, Mansoura faculty of medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05115708
- Sponsor's protocol ID
- R.21.10.1477
- Status last verified
- Oct 2021
- First submitted
- 30 Oct 2021
- Last updated
- 10 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: share primitive data as supplementary digital content
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma
- ClinicalTrials.gov ID
- NCT05115708
- Acronym / sponsor ID
- R.21.10.1477
- Conditions
- Glaucoma, Congenital Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Nov 2021 (estimated)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 10 Nov 2021 (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.
This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.
Detailed description
Introduction:
Ab externo viscotrabeculotomy is known as an effective surgical procedure used for managing primary congenital glaucoma (PCG) in which the Schlemm's canal (SC) is identified and a metal probe is inserted into the canal and rotated into the anterior chamber (AC) to perforate the SC inner wall.
Recently, Kahook dual blade (KDB) have been developed as one of the micro-invasive glaucoma surgical tools which removes a strip of the trabecular meshwork(TM) at the angle with superiority to simple goniotomy in treating the angle pathology in PCG.
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy is a simple procedure usually performed at the time of cataract surgery. It doesn't require sutures, and it carries no risk of bleb leaks or infections. It has a a quicker postoperative visual recovery than most other glaucoma treatments. The KDB device is specifically designed to produce targeted and fine tuned parallel incisions in the trabecular meshwork tissue for a quick and effective glaucoma treatment. The KDB's unique design enables precise excision of diseased trabecular meshwork (TM) to access multiple collector channels.
The KDB's unique design enables the operator to perform excisional goniotomy both during cataract surgery and as a stand alone procedure. The Kahook Dual Blade is a precise, intuitive surgical instrument utilized to perform excisional goniotomy.
Purpose:
This prospective study aims to compare KDB ab-interno trabeculotomy to ab externo rigid probe viscotrabeculotomy in patients with PCG.
Methods:
Sixty eyes of with PCG underwent ab-interno trabeculotomy using a KDB or ab externo viscotrabeculotomy. The study will be conducted at Mansoura university ophthalmic Center. Follow-up visits were scheduled at these post-operative dates: first day, first week, first month, 3rd month and then every 3 months for 2 years. Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.
Preoperative data including age, sex, laterality, type of glaucoma, ocular history, number of glaucoma medications, IOP, cup to disc ratio, and central corneal thickness (CCT) were record. Postoperative data included follow-up durations.
Statistical analysis:
All statistical analysis will be accomplished using IBM SPSS version 20. Assessment of the data normality will be done using both Histogram plot and Shapiro-Wilk's test. Wilcoxon test was used to compare the preoperative and postoperative variables in each group. The comparison between the two groups will be done using Mann-Whitney test for numerical variables and Chi-square test for categorical variables. Kaplan-Meier survival curve will be plotted to estimate the mean survival time and probabilities of failure at different follow-up stages in the both groups. For all tests, P value of less than 0.05 will be considered significant.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
- Model description
- Kahook dual blade ab-interno Trabeculotomy versus ab externo viscotrabeculotomy in treatment of primary congenital glaucoma.
| Arm | Type | Receives |
|---|---|---|
| Kahook dual blade ab-interno Trabeculotomy | Active comparator | Procedure: The Kahook dual blade® (KDB) assisted ab-interno trabeculotomyThe Kahook dual blade® (KDB) assisted ab-interno trabeculotomy |
| ab externo viscotrabeculotomy | Active comparator | Procedure: ab externo viscotrabeculotomyIn brief, a fornix-based conjunctival incision is followed by fashioning and dissection of a triangular scleral flap. Radial incisions at the limbus followed to identify Schlemm's canal. viscotrabeculotomy, is performed by injection of high-viscosity sodium hyaluronate (Healon GV, Pfizer, NY) into Schlemm's canal prior to completion of the procedure with the metal trabeculotome. while a Nylon 10/0 suture in inserted into schlemm's canal in visco-circumferential-suture trabeculotomy group. |
Who may qualify
- Ages
- 1 month to 10 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- primary congenital glaucoma
Key exclusion criteria (1 listed)
- secondary congenital glaucoma
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 |
|---|---|---|
| ab externo viscotrabeculotomyIn brief, a fornix-based conjunctival incision is followed by fashioning and dissection of a triangular scleral flap. Radial incisions at the limbus followed to identify Schlemm's canal. viscotrabeculotomy, is performed by injection of high-viscosity sodium hyaluronate (Healon GV, Pfizer, NY) into Schlemm's canal prior to completion of the procedure with the metal trabeculotome. while a Nylon 10/0 suture in inserted into schlemm's canal in visco-circumferential-suture trabeculotomy group | Procedure or surgery | ab externo viscotrabeculotomy |
| The Kahook dual blade® (KDB) assisted ab-interno trabeculotomyThe Kahook dual blade® (KDB) assisted ab-interno trabeculotomy | Procedure or surgery | Kahook dual blade ab-interno Trabeculotomy |
Primary outcome
IOP
Time frame: 2 years
Complete success was defined as an IOP from 6 to 17 mmHg at the 2-year follow-up visit, without AGM or further surgical interventions, without any sign of glaucoma progression (increasing corneal diameter, axial length or cup/disc ratio) and without visual devastating complications. Qualified success was defined as fulfilling the same criteria but with the use of AGM.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2021.
- Individual participant dataSharing planned: Yes. share primitive data as supplementary digital content
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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.
Ahmed S Elwehidy, DM study chair
Mansoura faculty of medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ab externo viscotrabeculotomy and The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy in people with Glaucoma and Congenital Glaucoma, run by Mansoura 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: status not confirmed, as of the sponsor's last update on 10 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Abdelkader, MD, FRCS (01004314242, dramrabdelkader@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IOP (time frame: 2 years). 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 Nov 2021.