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Status unknownNCT05115708Updated Nov 10, 2021

Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma

An interventional study of ab externo viscotrabeculotomy and The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy in Glaucoma and Congenital Glaucoma, sponsored by Mansoura University. Status unknown at 1 site in Egypt. Open to participants aged 1 Month to 10 Years. Per ClinicalTrials.gov, last updated 2021-11-10.

Sponsored by Mansoura University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2021), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
1 Month to 10 Years
Sex
All
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Study summary

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.

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Conditions studied

  • Glaucoma
  • Congenital Glaucoma
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In context

Glaucoma

1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.

This study's planned enrollment of 60 is close to the median of 65 across 1,272 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
1 Month to 10 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

primary congenital glaucoma

Exclusion criteria

Exclusion Criteria:

secondary congenital glaucoma

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
60 participants (estimated)

Study arms

  • Active comparator
    Kahook dual blade ab-interno Trabeculotomy

    The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

    Procedure: The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

  • Active comparator
    ab externo viscotrabeculotomy

    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.

    Procedure: ab externo viscotrabeculotomy

Interventions

  • Procedureab externo viscotrabeculotomy

    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

  • ProcedureThe Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

    The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 2 years

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Study locations

1 site
  • Mansoura university ophthalmic center
    Mansoura, 35516, Egypt
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References and documents

Individual participant data

Plan to share: Yes — share primitive data as supplementary digital content

Supporting information: Study protocol, Sap, Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 10, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05115708
Lead sponsor
Mansoura University
Responsible party
Amr Mohammed Elsayed Abdelkader (Assisstant professor of ophthalmology, Mansoura University) — Principal investigator
First posted
Nov 10, 2021
Start date
Nov 2021 (estimated)
Primary completion
Nov 2023 (estimated)
Completion
Nov 2024 (estimated)
Last update
Nov 10, 2021

Study contacts

Amr M Abdelkader, MD, FRCS
Contact
dramrabdelkader@gmail.com
01004314242
Ahmed s Elwehidy, MD
Contact
aselwehidy@yahoo.com
1009922107 ext. +20
Ahmed S Elwehidy, DM
study chair · Mansoura faculty of medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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