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

Primary Purpose

Glaucoma, Congenital Glaucoma

Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
ab externo viscotrabeculotomy
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

1 Month - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

primary congenital glaucoma

Exclusion Criteria:

secondary congenital glaucoma

Sites / Locations

  • Mansoura university ophthalmic center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Kahook dual blade ab-interno Trabeculotomy

ab externo viscotrabeculotomy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
October 30, 2021
Last Updated
November 9, 2021
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05115708
Brief Title
Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma
Official Title
Kahook Dual Blade Ab-interno Trabeculotomy Versus ab Externo Viscotrabeculotomy in Primary Congenital Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
November 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Congenital Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Kahook dual blade ab-interno Trabeculotomy versus ab externo viscotrabeculotomy in treatment of primary congenital glaucoma.
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kahook dual blade ab-interno Trabeculotomy
Arm Type
Active Comparator
Arm Description
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
Arm Title
ab externo viscotrabeculotomy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
ab externo viscotrabeculotomy
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
Intervention Description
The Kahook dual blade® (KDB) assisted ab-interno trabeculotomy
Primary Outcome Measure Information:
Title
IOP
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Month
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: primary congenital glaucoma Exclusion Criteria: secondary congenital glaucoma
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amr M Abdelkader, MD, FRCS
Phone
01004314242
Email
dramrabdelkader@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ahmed s Elwehidy, MD
Phone
1009922107
Ext
+20
Email
aselwehidy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed S Elwehidy, DM
Organizational Affiliation
Mansoura faculty of medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Mansoura university ophthalmic center
City
Mansoura
ZIP/Postal Code
35516
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Amr Abdelkader, MD, FRCS
Phone
01004314242
Ext
020
Email
dramrabdelkader@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
share primitive data as supplementary digital content

Learn more about this trial

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

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