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

NCT06189326 | Unknown

• 1 other identifier: primary congenital glaucoma
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Congenital Glaucoma

Outcome Measures

Primary Outcomes (5)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

non-penetrating deep sclerectomy

ACTIVE COMPARATOR

Procedure: non-penetrating deep sclerectomy

primary combined trabeculotomy-trabeculectomy

ACTIVE COMPARATOR

Procedure: primary combined trabeculotomy-trabeculectomy

Interventions

non-penetrating deep sclerectomy PROCEDURE

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

non-penetrating deep sclerectomy

primary combined trabeculotomy-trabeculectomy PROCEDURE

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

primary combined trabeculotomy-trabeculectomy

Eligibility Criteria

• Age: 1 Year - 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• patients with anterior segment anomalies,
• secondary glaucoma
• previous anterior segment surgeries
• patients more than 6 years old

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Ehab tharwat

Damietta, New Damietta, 34517, Egypt

Location

MeSH Terms

Conditions

Hydrophthalmos

Condition Hierarchy (Ancestors)

Eye Abnormalities; Eye Diseases; Glaucoma, Open-Angle; Glaucoma; Ocular Hypertension; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 3, 2024
• Study Start: February 1, 2022
• Primary Completion: December 1, 2023
• Study Completion: February 1, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Locations

EG (1)