Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma

Congenital Glaucoma Clinical Trial

Official title:

Non-penetrating Deep Sclerectomy Versus Trabeculotomy- Trabeculectomy Operation in Treatment of Primary Congenital Glaucoma

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06189326
• Other study ID #: primary congenital glaucoma
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: February 1, 2024

Study information

• Verified date: December 2023
• Source: Al-Azhar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The high success rate of the non-penetrating deep sclerectomy (NPDS) procedure in adult glaucomatous patients motivated some glaucoma specialists to try it as an alternative procedure in childhood PCG. In deep sclerectomy, the surgeon fashions a partial-thickness scleral flap and excises the outer parts of both Schlemm's canal and trabecular meshwork without opening the eye, leaving a thin trabeculo-descemetic membrane. This membrane will guard against early postoperative hypotony due to the non-penetrating nature of the procedure.

The aim of this study is to assess the safety and efficacy outcomes of non-penetrating deep sclerectomy versus combined trabeculotomy-trabeculectomy in the treatment of congenital primary glaucoma

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 40
• Est. completion date: February 1, 2024
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 20 Years

Eligibility

Inclusion Criteria:

• patients with PCG younger than 6 years old with a HCD between 12-14 mm ware

Exclusion Criteria:

• patients with anterior segment anomalies,

• secondary glaucoma

• previous anterior segment surgeries

• patients more than 6 years old

Related Conditions & MeSH terms

• Congenital Glaucoma
• Glaucoma

Intervention

Procedure:
• non-penetrating deep sclerectomy
Non-penetrating deep sclerectomy (NPDS) is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma. This procedure was developed in an attempt to avoid many of the postoperative complications of trabeculectomy
• primary combined trabeculotomy-trabeculectomy
Combining trabeculotomy with trabeculectomy is one of the preferred surgical options, which showed favorable results in congenital glaucoma, and is advised mainly for treating moderate to severe forms of the disease, as the procedure provides dual pathways for aqueous drainage

Locations

Country	Name	City	State
Egypt	Ehab tharwat	Damieta	New Damietta

Sponsors (1)

Lead Sponsor	Collaborator
Al-Azhar University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intra Occular Pressure	Intraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye.; It is measured by applanation tonometer its unite is mmHg	Base line
Primary	Intra Occular Pressure	Intraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye.; It is measured by applanation tonometer its unite is mmHg	Post 1 week
Primary	Intra Occular Pressure	Intraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye.; It is measured by applanation tonometer its unite is mmHg	Post 1 month
Primary	Intra Occular Pressure	Intraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye.; It is measured by applanation tonometer its unite is mmHg	Post 3 month
Primary	Intra Occular Pressure	Intraocular pressure (IOP) is the fluid pressure of the eye. As pressure is a measure of force per area, IOP is a measurement involving the magnitude of the force exerted by the aqueous humor on the internal surface area of the anterior eye.; It is measured by applanation tonometer its unite is mmHg	Post 6 month